Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT03407612
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2018-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057925', 'term': 'Femoracetabular Impingement'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015915', 'term': 'Motion Therapy, Continuous Passive'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maria.munsch@osumc.edu', 'phone': '614-293-3600', 'title': 'Maria Munsch', 'organization': 'Jameson Crane Sports Medicine Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months from operation date', 'eventGroups': [{'id': 'EG000', 'title': 'CPM Used', 'description': 'These subjects received a continuous passive motion (CPM) device and were instructed to use it for 4-6 hours daily throughout the first two postoperative weeks following their arthroscopic labral repair. They were provided adequate education on how to operate the device. The subjects recorded their average usage of the CPM, as well as their personal perception of the CPM, at the postoperative 2 day, 7 day, and 14 day marks.\n\nContinuous Passive Motion: CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No CPM Used', 'description': 'No CPM was administered to these subjects.', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Patient Satisfaction and Functional Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CPM Used', 'description': 'These subjects received a continuous passive motion (CPM) device and were instructed to use it for 4-6 hours daily throughout the first two postoperative weeks following their arthroscopic labral repair. They were provided adequate education on how to operate the device. The subjects recorded their average usage of the CPM, as well as their personal perception of the CPM, at the postoperative 2 day, 7 day, and 14 day marks.\n\nContinuous Passive Motion: CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.'}, {'id': 'OG001', 'title': 'No CPM Used', 'description': 'No CPM was administered to these subjects.'}], 'classes': [{'title': 'Preoperative', 'categories': [{'measurements': [{'value': '64.5', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '62.7', 'spread': '15.0', 'groupId': 'OG001'}]}]}, {'title': '6 weeks postoperative', 'categories': [{'measurements': [{'value': '74.6', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '72.8', 'spread': '12.5', 'groupId': 'OG001'}]}]}, {'title': '12 weeks postoperative', 'categories': [{'measurements': [{'value': '81.1', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '81.5', 'spread': '11.4', 'groupId': 'OG001'}]}]}, {'title': '6 months postoperative', 'categories': [{'measurements': [{'value': '81.9', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '82.8', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'Improvement', 'categories': [{'measurements': [{'value': '17.0', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '20.2', 'spread': '15.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis considers the baseline HOS-ADL measures.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'p \\< 0.05 required for groups to have non-equivalent results.'}, {'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis considers the 6 week postoperative HOS-ADL measures.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'p \\< 0.05 required for groups to have non-equivalent results.'}, {'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis considers the 12 week postoperative HOS-ADL measures.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'p \\< 0.05 required for groups to have non-equivalent results.'}, {'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis considers the 6 month postoperative HOS-ADL measures.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'p \\< 0.05 required for groups to have non-equivalent results.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks, 12 weeks, and 6 months postoperatively', 'description': 'Hip Outcome Score Activities of Daily Living (HOS ADL) questionnaire completed at specific time points. Completion of the HOS ADL provides a score from 0 to 100, with a higher score corresponding to greater level of function. The improvement preoperative to 6 month postoperative scores was also computed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Analgesic Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CPM Used', 'description': 'These subjects received a continuous passive motion (CPM) device and were instructed to use it for 4-6 hours daily throughout the first two postoperative weeks following their arthroscopic labral repair. They were provided adequate education on how to operate the device. The subjects recorded their average usage of the CPM, as well as their personal perception of the CPM, at the postoperative 2 day, 7 day, and 14 day marks.\n\nContinuous Passive Motion: CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.'}, {'id': 'OG001', 'title': 'No CPM Used', 'description': 'No CPM was administered to these subjects.'}], 'classes': [{'categories': [{'measurements': [{'value': '239', 'spread': '269', 'groupId': 'OG000'}, {'value': '330', 'spread': '227', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'p \\< 0.05 required for groups to have non-equivalent results.'}], 'paramType': 'MEAN', 'timeFrame': 'Initial two postoperative weeks', 'description': 'Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications', 'unitOfMeasure': 'morphine equivalent doses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CPM Used', 'description': 'These subjects received a continuous passive motion (CPM) device and were instructed to use it for 4-6 hours daily throughout the first two postoperative weeks following their arthroscopic labral repair. They were provided adequate education on how to operate the device. The subjects recorded their average usage of the CPM, as well as their personal perception of the CPM, at the postoperative 2 day, 7 day, and 14 day marks.\n\nContinuous Passive Motion: CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.'}, {'id': 'OG001', 'title': 'No CPM Used', 'description': 'No CPM was administered to these subjects.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.94', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '4.23', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'p \\< 0.05 required for groups to have non-equivalent results.'}], 'paramType': 'MEAN', 'timeFrame': 'Initial two postoperative weeks', 'description': 'Change in pain level measured on a Likert-type scale from 0 to 10, with higher scores representing higher pain levels.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CPM Used', 'description': 'These subjects received a continuous passive motion (CPM) device and were instructed to use it for 4-6 hours daily throughout the first two postoperative weeks following their arthroscopic labral repair. They were provided adequate education on how to operate the device. The subjects recorded their average usage of the CPM, as well as their personal perception of the CPM, at the postoperative 2 day, 7 day, and 14 day marks.\n\nContinuous Passive Motion: CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.'}, {'id': 'FG001', 'title': 'No CPM Used', 'description': 'No CPM was administered to these subjects.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CPM Used', 'description': 'These subjects received a continuous passive motion (CPM) device and were instructed to use it for 4-6 hours daily throughout the first two postoperative weeks following their arthroscopic labral repair. They were provided adequate education on how to operate the device. The subjects recorded their average usage of the CPM, as well as their personal perception of the CPM, at the postoperative 2 day, 7 day, and 14 day marks.\n\nContinuous Passive Motion: CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.'}, {'id': 'BG001', 'title': 'No CPM Used', 'description': 'No CPM was administered to these subjects.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36.2', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '29.5', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '32.5', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.5', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '25.1', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '26.2', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hand Dominance', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Right Handed', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Left Handed', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2015-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2018-01-09', 'resultsFirstSubmitDate': '2018-04-05', 'studyFirstSubmitQcDate': '2018-01-16', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-07', 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Patient Satisfaction and Functional Outcome', 'timeFrame': 'Baseline and 6 weeks, 12 weeks, and 6 months postoperatively', 'description': 'Hip Outcome Score Activities of Daily Living (HOS ADL) questionnaire completed at specific time points. Completion of the HOS ADL provides a score from 0 to 100, with a higher score corresponding to greater level of function. The improvement preoperative to 6 month postoperative scores was also computed.'}], 'secondaryOutcomes': [{'measure': 'Analgesic Usage', 'timeFrame': 'Initial two postoperative weeks', 'description': 'Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications'}, {'measure': 'Pain Level', 'timeFrame': 'Initial two postoperative weeks', 'description': 'Change in pain level measured on a Likert-type scale from 0 to 10, with higher scores representing higher pain levels.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['continuous passive motion device', 'HOS-ADL', 'hip arthroscopy'], 'conditions': ['Femoro Acetabular Impingement', 'Pain, Postoperative', 'Hip Labral Tear']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure whether CPM (continuous passive motion) usage improves outcomes following arthroscopic hip surgery that includes labral repair. Investigators tested the hypothesis that CPM usage reduces pain levels and pain medication use and improves function in individuals who undergo hip arthroscopy.', 'detailedDescription': 'Subjects undergoing primary hip arthroscopy for acetabular labral repair were randomized to determine whether they would receive a CPM. Those subjects receiving a CPM were instructed to use it for 4-6 hours daily throughout the first two postoperative weeks. The total number of pain medications and average pain scores over the two weeks, as well as Hip Outcome Score Activity of Daily Living (HOS ADL) scores at standard time points were compared via a two sample t-test and intention-to-treat analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing hip arthroscopy to repair a torn labrum\n\nExclusion Criteria:\n\n* pregnancy\n* revision surgery\n* bilateral surgery'}, 'identificationModule': {'nctId': 'NCT03407612', 'briefTitle': 'Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'The Effect of Continuous Passive Motion on Pain Control Following Hip Arthroscopy', 'orgStudyIdInfo': {'id': '2011H0416'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CPM', 'description': 'These subjects received a continuous passive motion (CPM) device and were instructed to use it for 4-6 hours daily throughout the first two postoperative weeks following their arthroscopic labral repair. They were provided adequate education on how to operate the device. The subjects recorded their average usage of the CPM, as well as their personal perception of the CPM, at the postoperative 2 day, 7 day, and 14 day marks.', 'interventionNames': ['Device: Continuous Passive Motion']}, {'type': 'NO_INTERVENTION', 'label': 'No CPM', 'description': 'No CPM was administered to these subjects.'}], 'interventions': [{'name': 'Continuous Passive Motion', 'type': 'DEVICE', 'description': 'CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.', 'armGroupLabels': ['CPM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'John Ryan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'John Ryan', 'investigatorAffiliation': 'Ohio State University'}}}}