Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-08 @ 3:31 AM
Study NCT ID:
NCT02468934
Status:
COMPLETED
Last Update Posted:
2018-09-04
First Post:
2015-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016503', 'term': 'Drug Delivery Systems'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'support@SPRTherapeutics.com', 'phone': '216-378-9108', 'title': 'Clinical Affairs', 'organization': 'SPR Therapeautics'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '21 months (from the time the first subject was enrolled to when the last subjects completed the study)', 'eventGroups': [{'id': 'EG000', 'title': 'Enrolled/Received Leads', 'description': 'This group includes subjects that were consented, met eligibility criteria, and received Leads.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 18, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea/Upset Stomach', 'notes': 'One event was study-related, and the other was not', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Agitation', 'notes': 'One event was study-related, and the other two were not', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Common Cold', 'notes': 'Not study-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Small dehiscence at Total Knee Arthroplasty (TKA) surgical site', 'notes': 'Not study-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Iliotibial Band Tendonitis', 'notes': 'Not study-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulled Hamstring', 'notes': 'Not study-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Pain/Cramping', 'notes': 'Three events were study-related, and one was not', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Pain (Hip and Leg)', 'notes': 'Two events were not study-related, and the relationship to the study was unable to be determined for the other event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Relationship to study unable to be determined', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain due to Stimulation', 'notes': 'Study-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shocks at Lead Exit Site', 'notes': 'Study-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Frequency', 'notes': 'Not study-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'notes': 'Not study-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin irritation or bruising at Lead exit site', 'notes': 'Study-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin irritation/dermatitis from bandages', 'notes': 'Study-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin irritation from SPRINT Pad', 'notes': 'Study-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-specified skin irritation', 'notes': 'Two events were study-related, and the other one was not', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising', 'notes': 'Not study-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching', 'notes': 'Relationship to study unable to be determined', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Affected Leg Swelling', 'notes': 'Study-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Knee Stiffness/Decreased Range of Motion', 'notes': 'Not study-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Ileus', 'notes': 'Not study-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Knee Pain While Walking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Underwent Total Knee Arthroplasty (TKA)', 'description': 'These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '0.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))', 'description': 'Subjects were asked to complete daily diaries to track their average pain intensity while walking during the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average score for each diary period was calculated across subjects, and the mean scores for weeks 1-4 is reported.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants That Experienced at Least One Study-Related Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled/Received Leads', 'description': 'This group includes subjects that were consented, met eligibility criteria, and received Leads.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Total of 21 months (from when the first subjects enrolled to when the last subject completed the study)', 'description': 'At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition has occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Knee Pain Over the Last 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Underwent Total Knee Arthroplasty (TKA)', 'description': 'These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty procedures.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '0.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))', 'description': 'Subjects were asked to complete daily diaries to track their average pain intensity in the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average score for each diary period was calculated across subjects, and the mean score for weeks 1-4 is reported.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Knee Pain at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Underwent Total Knee Arthroplasty (TKA)', 'description': 'These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty procedures.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '0.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))', 'description': 'Subjects were asked to complete daily diaries to track their average pain intensity at rest in the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average score for each diary period was calculated across subjects, and the mean score for weeks 1-4 is reported.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Amount of Analgesic Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Underwent Total Knee Arthroplasty (TKA)', 'description': 'These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '33.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Visit 4 (Day of Surgery) and Visits 6-11 (weeks 1-6 post-Total Knee Arthroplasty (TKA))', 'description': 'The amount and type of analgesics used by subjects was recorded in daily diaries. Narcotic usage was converted into a morphine equivalent dosage (MED), which is measured in units of morphine milligram equivalents (MME). Diaries were collected at various visits throughout the study, and for consistency, these data were translated into post-operative days. The average MED was calculated for each subject for the first 42 days (6 weeks) following surgery, and the median of these averages was determined across subjects.', 'unitOfMeasure': 'MME (Morphine Milligram Equivalents)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not available for: one subject during Post-op Week 1, three subjects for Weeks 2 and 4, four subjects during Weeks 3 and 5, and for seven subjects during Post-op Week 6.'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Experienced at Least One Opioid-Related Side Effect', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Underwent Total Knee Arthroplasty (TKA)', 'description': 'These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.'}], 'classes': [{'title': 'Visit 1 (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Visit 2 (Lead Placement)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Visit 5 (In-Hospital)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Visit 6 (1-week Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Visit 7 (2-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Visit 8 (3-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Visit 9 (4-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Visit 10 (5-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Visit 11 (6-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Visit 12 (2-months Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Visit 13 (3-months Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 1 (Baseline), Visit 2 (Lead Placement), Visits 5-13 (in-hospital days through 3-months post-Total Knee Arthroplasty (TKA))', 'description': 'Throughout the study, subjects were asked if they experienced any side effects related to opioid pain medications. The occurrences of these side effects were recorded and were not reported as Adverse Events. The number of subjects that experienced at least one opioid-related side effect at each visit is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for: eight subjects at Visit 2, two subjects at Visit 10, and one subject at Visit 12.'}, {'type': 'SECONDARY', 'title': 'Time to Achieve 90 Degrees Flexion in Affected Knee', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Underwent Total Knee Arthroplasty (TKA)', 'description': 'These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.'}], 'classes': [{'title': 'PROM - Stimulation Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '44.0'}]}]}, {'title': 'PROM - Stimulation On', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '17.0'}]}]}, {'title': 'AROM - Stimulation Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.5', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '44.0'}]}]}, {'title': 'AROM - Stimulation On', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '17.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Visit 2 (Lead Placement), Visit 7 (3-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)', 'description': 'Active range of motion (AROM; no assistance from clinical staff) and passive range of motion (PROM; assisted by clinical staff) was assessed with both stimulation on and off. The time that it took subjects to achieve the milestone of 90 degrees of knee flexion in their affected leg is reported.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Three subjects did not meet 90 degrees of flexion with stimulation on by Visit 11 (End of Treatment) for both active range of motion (AROM) and passive range of motion (PROM). Data was not collected for four subjects for PROM with stimulation on and for three subjects for AROM with stimulation on.'}, {'type': 'SECONDARY', 'title': 'Timed Up and Go (TUG) Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Underwent Total Knee Arthroplasty (TKA)', 'description': 'These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.'}], 'classes': [{'title': 'Time at Visit 1 (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '14.0'}]}]}, {'title': 'Time at Visit 5 (In-Hospital)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000', 'lowerLimit': '28.0', 'upperLimit': '52.0'}]}]}, {'title': 'Time at Visit 7 (2-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '17.0'}]}]}, {'title': 'Time at Visit 11 (6-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '13.0'}]}]}, {'title': 'Time at Visit 13 (3-months Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '11.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Visit 1 (Baseline), Visit 5 (In-Hospital), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)', 'description': 'Subjects began this test from a seated position in a standard chair and were timed while they stood up, walked to a marked point 10 feet away (at a normal, safe pace), returned to the chair, and sat down. Timed Up and Go (TUG) test times are expected to be greater immediately after surgery as compared to baseline.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for two subjects at Visit 5 and another subject was physically unable to complete the test. Data was not collected for one subject at Visit 7.'}, {'type': 'SECONDARY', 'title': '6 Minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Underwent Total Knee Arthroplasty (TKA)', 'description': 'These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.'}], 'classes': [{'title': 'Visit 1 (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '363.0', 'spread': '15.14', 'groupId': 'OG000'}]}]}, {'title': 'Visit 7 (2-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '289.0', 'spread': '21.55', 'groupId': 'OG000'}]}]}, {'title': 'Visit 11 (6-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '365.8', 'spread': '17.87', 'groupId': 'OG000'}]}]}, {'title': 'Visit 13 (3-months Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '410.3', 'spread': '16.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1 (Baseline), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)', 'description': 'The total distance that a subject could walk in 6 minutes was recorded, and the mean distance was determined across subjects. 6 Minute Walk Test distances are expected to be reduced immediately after surgery as compared to baseline.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject at Visit 1 and two subjects at Visit 7 were physically unable to complete the test. Data was not collected for an additional subject at Visit 7.'}, {'type': 'SECONDARY', 'title': 'Fixed Distance Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Underwent Total Knee Arthroplasty (TKA)', 'description': 'These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.'}], 'classes': [{'title': 'Visit 1 (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '22.0'}]}]}, {'title': 'Visit 5 (In-Hospital)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000', 'lowerLimit': '44.0', 'upperLimit': '72.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Visit 1 (Baseline) and Visit 5 (In-Hospital)', 'description': 'The amount of time it took subjects to walk a fixed distance of 20 meters was recorded.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject at Visits 1 and 5 was physically unable to complete the test. Data was not collected for two additional subjects at Visit 5, and another subject walked a fixed distance greater than 20 meters during the test so their results are not comparable.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline on the Western Ontario McMaster University Osteoarthritis Index (WOMAC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Underwent Total Knee Arthroplasty (TKA)', 'description': 'These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.'}], 'classes': [{'title': 'Visit 5 (In-Hospital)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'groupId': 'OG000', 'lowerLimit': '-38.3', 'upperLimit': '22.7'}]}]}, {'title': 'Visit 7 (2-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000', 'lowerLimit': '-24.1', 'upperLimit': '58.3'}]}]}, {'title': 'Visit 11 (6-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.5', 'groupId': 'OG000', 'lowerLimit': '37.9', 'upperLimit': '73.3'}]}]}, {'title': 'Visit 13 (3-months Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000', 'lowerLimit': '68.9', 'upperLimit': '96.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Visit 1 (Baseline), Visit 5 (In-Hospital), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)', 'description': "The Western Ontario McMaster University Osteoarthritis Index (WOMAC) questionnaire consists of 24 items that evaluate pain, stiffness, and physical functional disability. Each item is scored on an 11-point numerical rating scale from 0 to 10, where higher scores indicate greater pain, stiffness, and disability. For each subject, the scores from each of the 24 items were summed to calculate the subject's total score, with a minimum score of 0 and a maximum score of 240. Percent change from baseline was calculated for each subject at each time point (i.e., value at Visit 5 vs. Baseline rating, value at Visit 7 vs. Baseline rating, value at Visit 11 vs. Baseline rating, and value at Visit 13 vs. Baseline rating). The median percent change across subjects was determined. Negative values indicate worsening since Baseline, while positive values indicate improvement from Baseline.\n\nPercent improvement = 100 x (\\[rating at each study visit\\]-\\[rating at baseline\\]) / \\[rating at baseline\\].", 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for two subjects at Visit 5.'}, {'type': 'SECONDARY', 'title': 'Knee Pain Interference With Daily Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Underwent Total Knee Arthroplasty (TKA)', 'description': 'These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.'}], 'classes': [{'title': 'Visit 1 (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '6.6'}]}]}, {'title': 'Visit 2 (Lead Placement)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '6.6'}]}]}, {'title': 'Visit 5 (In-Hospital)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '5.2'}]}]}, {'title': 'Visit 6 (1-week Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '4.8'}]}]}, {'title': 'Visit 7 (2-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '5.3'}]}]}, {'title': 'Visit 8 (3-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '4.5'}]}]}, {'title': 'Visit 9 (4-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '5.3'}]}]}, {'title': 'Visit 10 (5-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '3.6'}]}]}, {'title': 'Visit 11 (6-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '2.6'}]}]}, {'title': 'Visit 12 (2-months Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.4'}]}]}, {'title': 'Visit 13 (3-months Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Visit 1 (Baseline), Visit 2 (Lead Placement), Visits 5-13 (in-hospital days through 3-months post-Total Knee Arthroplasty (TKA))', 'description': 'Subjects were asked to rate the degree to which their knee pain has interfered with 7 different aspects of their daily life on a scale from 0 to 10, with higher scores indicating greater interference. Those 7 scores were averaged for each subject to provide an overall pain interference score, with a possible range of 0 to 10 with higher scores indicating greater interference. The median score was then calculated across subjects.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for: 10 subjects at Visit 2, two subjects at Visit 10, and one subject at Visit 12.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Underwent Total Knee Arthroplasty (TKA)', 'description': 'These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.'}], 'classes': [{'title': 'Visit 5 (In-Hospital)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Meaningful Improvement', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Minimal or No Change', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Meaningfully Worse', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Visit 6 (1-week Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Meaningful Improvement', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Minimal or No Change', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Meaningfully Worse', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Visit 7 (2-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Meaningful Improvement', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Minimal or No Change', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Meaningfully Worse', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Visit 8 (3-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Meaningful Improvement', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Minimal or No Change', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Meaningfully Worse', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Visit 9 (4-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Meaningful Improvement', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Minimal or No Change', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Meaningfully Worse', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Visit 10 (5-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Meaningful Improvement', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Minimal or No Change', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Meaningfully Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Visit 11 (6-weeks Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Meaningful Improvement', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Minimal or No Change', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Meaningfully Worse', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Visit 12 (2-months Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Meaningful Improvement', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Minimal or No Change', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Meaningfully Worse', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Visit 13 (3-months Post-TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Meaningful Improvement', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Minimal or No Change', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Meaningfully Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visits 5-13 (in-hospital through 3-months post-Total Knee Arthroplasty (TKA))', 'description': 'The Patient Global Impression of Change (PGIC) asks subjects to rate their improvement with treatment on a 7-point scale ranging from "very much worse" to "very much improved" as compared to before their knee replacement surgery. The subjects combine all the components of their experience into one overall score. Ratings of Much- or Very Much Improved are considered Meaningful Improvements; similarly, ratings of Much- or Very Much Worse are categorized as Meaningfully Worse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for two subjects at Visit 5, for three subjects at Visit 10, and for one subject at Visit 12.'}, {'type': 'SECONDARY', 'title': 'Pain Catastrophizing Scale (PCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Underwent Total Knee Arthroplasty (TKA)', 'description': 'These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.'}], 'classes': [{'title': 'Visit 1 (Baseline)', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '11.3'}]}]}, {'title': 'Visit 11 (6-weeks Post-TKA)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.0'}]}]}, {'title': 'Visit 13 (3-months Post-TKA)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Visit 1 (Baseline), Visit 11 (6-weeks post-Total Knee Arthroplasty (TKA)), Visit 13 (3-months post-TKA)', 'description': 'The Pain Catastrophizing Scale (PCS) questionnaire has 13 questions that assess rumination, magnification, and helplessness. Subjects are asked to think back on painful experiences in the past and reflect on how often they had specific thoughts or feelings. Each of the 13 questions is scored on a 5-point scale where 0 represents "not at all," and 4 represents "all the time." The scores from each question were summed for each subject to provide a total PCS score, with a possible range from 0 to 52 with higher scores indicating a greater tendency to catastrophize pain (i.e. a higher score indicates a worse outcome). The median scores were then calculated across all subjects.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Meet Recovery Milestones up to Three Months Post-Total Knee Arthroplasty (TKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Underwent Total Knee Arthroplasty (TKA)', 'description': 'These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.'}], 'classes': [{'title': 'Pain controlled without nerve block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}, {'title': 'Walked with assistive device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}, {'title': 'Walked without assistive device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '38.3'}]}]}, {'title': 'Walked 30 meters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.3'}]}]}, {'title': 'Able to climb half flight of stairs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '19.0'}]}]}, {'title': 'Met hospital discharge criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}, {'title': 'Discharged from hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}, {'title': 'Cleared to drive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '39.5'}]}]}, {'title': 'Returned to work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '34.5'}]}]}, {'title': 'Cessation of all opioid medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '44.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day of Surgery through completion of milestone or 3-months from Day of Surgery, whichever came first', 'description': 'Participants were queried weekly from the date of their Total Knee Arthroplasty (TKA) until they met specific, post-surgical recovery milestones. Participants were queried up through the time at which they meet each milestone or through their completion of the study, whichever came first (up to three months post-surgery).', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not available for climbing stairs and discharge destination for 3 subjects and for discharge criteria and clearance to drive for one. Data were not collected for clearance to work in 2 subjects, and 10 subjects were retired. Opioid cessation data were not collected for 1 subject, and 2 subjects did not cease opioids during the study.'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Underwent Total Knee Arthroplasty (TKA)', 'description': 'These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.'}], 'classes': [{'title': 'Tolerated Lead placement with some/no discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Reported stimulation felt comfortable/soothing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Reported immediate pain relief (0-5 minutes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Would recommend stimulation therapy to a friend', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Prefer stimulation therapy to pain medication use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Wanted stimulation for longer time period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 11 (6-weeks post-Total Knee Arthroplasty (TKA))', 'description': 'Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the SPRINT Stimulation System as a method for managing post-surgical pain.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two subjects did not answer the question regarding the amount of time it took to feel pain relief from stimulation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Consented Subjects', 'description': 'These subjects signed an informed consent form and met all eligibility criteria.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Enrolled/Received Leads', 'comment': 'Subjects consented, met eligibility criteria, and continued with SPRINT Lead placement.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Underwent Total Knee Arthroplasty', 'comment': 'Subjects consented, met eligibility criteria, received Leads, and underwent total knee arthroplasty.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Recruitment began September 2015 (with first subject enrollment in October 2015) and was concluded in February 2017. Subjects were screened for the study from a pool of candidates scheduled to undergo a primary unilateral total knee replacement procedure.', 'preAssignmentDetails': 'After obtaining informed consent, subjects were evaluated for eligibility.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enrolled/Received Leads', 'description': 'This group includes subjects that were consented, met eligibility criteria, and received Leads.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.9', 'spread': '8.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Affected Leg', 'classes': [{'title': 'Left Leg', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Right Leg', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Reason for Total Knee Arthroplasty (TKA)', 'classes': [{'categories': [{'title': 'Osteoarthritis', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Rheumatoid Arthritis', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Trauma', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Post-Traumatic Arthritis', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The reason that each subject was scheduled to undergo a primary unilateral total knee arthroplasty (also known as total knee replacement).', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This group includes subjects that were consented, met eligibility criteria, and received Leads.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-11-13', 'size': 3598682, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-07-17T15:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-30', 'studyFirstSubmitDate': '2015-04-22', 'resultsFirstSubmitDate': '2018-07-17', 'studyFirstSubmitQcDate': '2015-06-10', 'lastUpdatePostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-30', 'studyFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Knee Pain While Walking', 'timeFrame': 'Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))', 'description': 'Subjects were asked to complete daily diaries to track their average pain intensity while walking during the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average score for each diary period was calculated across subjects, and the mean scores for weeks 1-4 is reported.'}, {'measure': 'Number of Participants That Experienced at Least One Study-Related Adverse Event', 'timeFrame': 'Total of 21 months (from when the first subjects enrolled to when the last subject completed the study)', 'description': 'At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition has occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.'}], 'secondaryOutcomes': [{'measure': 'Average Knee Pain Over the Last 24 Hours', 'timeFrame': 'Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))', 'description': 'Subjects were asked to complete daily diaries to track their average pain intensity in the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average score for each diary period was calculated across subjects, and the mean score for weeks 1-4 is reported.'}, {'measure': 'Average Knee Pain at Rest', 'timeFrame': 'Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))', 'description': 'Subjects were asked to complete daily diaries to track their average pain intensity at rest in the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average score for each diary period was calculated across subjects, and the mean score for weeks 1-4 is reported.'}, {'measure': 'Amount of Analgesic Usage', 'timeFrame': 'Visit 4 (Day of Surgery) and Visits 6-11 (weeks 1-6 post-Total Knee Arthroplasty (TKA))', 'description': 'The amount and type of analgesics used by subjects was recorded in daily diaries. Narcotic usage was converted into a morphine equivalent dosage (MED), which is measured in units of morphine milligram equivalents (MME). Diaries were collected at various visits throughout the study, and for consistency, these data were translated into post-operative days. The average MED was calculated for each subject for the first 42 days (6 weeks) following surgery, and the median of these averages was determined across subjects.'}, {'measure': 'Number of Participants That Experienced at Least One Opioid-Related Side Effect', 'timeFrame': 'Visit 1 (Baseline), Visit 2 (Lead Placement), Visits 5-13 (in-hospital days through 3-months post-Total Knee Arthroplasty (TKA))', 'description': 'Throughout the study, subjects were asked if they experienced any side effects related to opioid pain medications. The occurrences of these side effects were recorded and were not reported as Adverse Events. The number of subjects that experienced at least one opioid-related side effect at each visit is reported.'}, {'measure': 'Time to Achieve 90 Degrees Flexion in Affected Knee', 'timeFrame': 'Visit 2 (Lead Placement), Visit 7 (3-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)', 'description': 'Active range of motion (AROM; no assistance from clinical staff) and passive range of motion (PROM; assisted by clinical staff) was assessed with both stimulation on and off. The time that it took subjects to achieve the milestone of 90 degrees of knee flexion in their affected leg is reported.'}, {'measure': 'Timed Up and Go (TUG) Test', 'timeFrame': 'Visit 1 (Baseline), Visit 5 (In-Hospital), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)', 'description': 'Subjects began this test from a seated position in a standard chair and were timed while they stood up, walked to a marked point 10 feet away (at a normal, safe pace), returned to the chair, and sat down. Timed Up and Go (TUG) test times are expected to be greater immediately after surgery as compared to baseline.'}, {'measure': '6 Minute Walk Test (6MWT)', 'timeFrame': 'Visit 1 (Baseline), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)', 'description': 'The total distance that a subject could walk in 6 minutes was recorded, and the mean distance was determined across subjects. 6 Minute Walk Test distances are expected to be reduced immediately after surgery as compared to baseline.'}, {'measure': 'Fixed Distance Walk Test', 'timeFrame': 'Visit 1 (Baseline) and Visit 5 (In-Hospital)', 'description': 'The amount of time it took subjects to walk a fixed distance of 20 meters was recorded.'}, {'measure': 'Percent Change From Baseline on the Western Ontario McMaster University Osteoarthritis Index (WOMAC)', 'timeFrame': 'Visit 1 (Baseline), Visit 5 (In-Hospital), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)', 'description': "The Western Ontario McMaster University Osteoarthritis Index (WOMAC) questionnaire consists of 24 items that evaluate pain, stiffness, and physical functional disability. Each item is scored on an 11-point numerical rating scale from 0 to 10, where higher scores indicate greater pain, stiffness, and disability. For each subject, the scores from each of the 24 items were summed to calculate the subject's total score, with a minimum score of 0 and a maximum score of 240. Percent change from baseline was calculated for each subject at each time point (i.e., value at Visit 5 vs. Baseline rating, value at Visit 7 vs. Baseline rating, value at Visit 11 vs. Baseline rating, and value at Visit 13 vs. Baseline rating). The median percent change across subjects was determined. Negative values indicate worsening since Baseline, while positive values indicate improvement from Baseline.\n\nPercent improvement = 100 x (\\[rating at each study visit\\]-\\[rating at baseline\\]) / \\[rating at baseline\\]."}, {'measure': 'Knee Pain Interference With Daily Activities', 'timeFrame': 'Visit 1 (Baseline), Visit 2 (Lead Placement), Visits 5-13 (in-hospital days through 3-months post-Total Knee Arthroplasty (TKA))', 'description': 'Subjects were asked to rate the degree to which their knee pain has interfered with 7 different aspects of their daily life on a scale from 0 to 10, with higher scores indicating greater interference. Those 7 scores were averaged for each subject to provide an overall pain interference score, with a possible range of 0 to 10 with higher scores indicating greater interference. The median score was then calculated across subjects.'}, {'measure': 'Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey', 'timeFrame': 'Visits 5-13 (in-hospital through 3-months post-Total Knee Arthroplasty (TKA))', 'description': 'The Patient Global Impression of Change (PGIC) asks subjects to rate their improvement with treatment on a 7-point scale ranging from "very much worse" to "very much improved" as compared to before their knee replacement surgery. The subjects combine all the components of their experience into one overall score. Ratings of Much- or Very Much Improved are considered Meaningful Improvements; similarly, ratings of Much- or Very Much Worse are categorized as Meaningfully Worse.'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'Visit 1 (Baseline), Visit 11 (6-weeks post-Total Knee Arthroplasty (TKA)), Visit 13 (3-months post-TKA)', 'description': 'The Pain Catastrophizing Scale (PCS) questionnaire has 13 questions that assess rumination, magnification, and helplessness. Subjects are asked to think back on painful experiences in the past and reflect on how often they had specific thoughts or feelings. Each of the 13 questions is scored on a 5-point scale where 0 represents "not at all," and 4 represents "all the time." The scores from each question were summed for each subject to provide a total PCS score, with a possible range from 0 to 52 with higher scores indicating a greater tendency to catastrophize pain (i.e. a higher score indicates a worse outcome). The median scores were then calculated across all subjects.'}, {'measure': 'Time to Meet Recovery Milestones up to Three Months Post-Total Knee Arthroplasty (TKA)', 'timeFrame': 'From Day of Surgery through completion of milestone or 3-months from Day of Surgery, whichever came first', 'description': 'Participants were queried weekly from the date of their Total Knee Arthroplasty (TKA) until they met specific, post-surgical recovery milestones. Participants were queried up through the time at which they meet each milestone or through their completion of the study, whichever came first (up to three months post-surgery).'}, {'measure': 'Subject Satisfaction Survey', 'timeFrame': 'Visit 11 (6-weeks post-Total Knee Arthroplasty (TKA))', 'description': 'Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the SPRINT Stimulation System as a method for managing post-surgical pain.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['electrical stimulation', 'neurostimulation', 'neuromodulation', 'TKA pain', 'pain following total knee replacement', 'total knee arthroplasty'], 'conditions': ['Total Knee Replacement', 'Total Knee Arthroplasty', 'Pain', 'Postoperative Pain', 'Orthopedic Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce pain following total knee replacement (or total knee arthroplasty (TKA)). This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the leg that received the knee replacement. The SPRINT System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* At least 21 years old\n* Scheduled to undergo a primary unilateral total knee replacement procedure\n\nKey Exclusion Criteria:\n\n* Body Mass Index (BMI) \\> 40 kg/m2\n* Compromised immune system based on medical history\n* History of valvular heart disease\n* Implanted electronic device\n* Joint or overlying skin infection of the affected limb\n* History of recurrent skin infections\n* Bleeding disorder\n* Allergy to skin surface electrodes and/or medical-grade adhesive tapes\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT02468934', 'briefTitle': 'Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System', 'organization': {'class': 'INDUSTRY', 'fullName': 'SPR Therapeutics, Inc.'}, 'officialTitle': 'A Prospective Case Series Study of SPR Peripheral Nerve Stimulation (PNS) Therapy for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Utilizing Preoperative Lead Placement', 'orgStudyIdInfo': {'id': '0141-CSP-000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peripheral Nerve Stimulation', 'description': 'All study subjects will have up to 2 Smartpatch Leads placed in their leg that underwent total knee replacement, will use the SPRINT Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.', 'interventionNames': ['Device: SPRINT Peripheral Nerve Stimulation (PNS) System']}], 'interventions': [{'name': 'SPRINT Peripheral Nerve Stimulation (PNS) System', 'type': 'DEVICE', 'otherNames': ['Smartpatch', 'Smartpatch System', 'SPRINT System'], 'description': 'The SPRINT System is an Investigational Device which delivers mild electrical stimulation to nerves in the leg that underwent lead placement. The SPRINT System includes a small wire (called a "Lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).', 'armGroupLabels': ['Peripheral Nerve Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '22710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43054', 'city': 'New Albany', 'state': 'Ohio', 'country': 'United States', 'facility': 'Joint Implant Surgeons', 'geoPoint': {'lat': 40.08117, 'lon': -82.80879}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SPR Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}