Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-03-04 @ 7:00 AM
Study NCT ID:
NCT02626533
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2015-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'KirkseyM@hss.edu', 'phone': '2126061036', 'title': 'Dr. Meghan Kirksey', 'organization': 'Hospital for Special Surgery, Anesthesiology'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Total Knee Arthroplasty Patients', 'description': 'Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients, and questionnaires will be administered to assess pain and stiffness.\n\nTotal Knee Arthroplasty: Patients will undergo total unilateral knee arthroplasty for osteoarthritis.', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 0, 'seriousNumAtRisk': 162, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Presence of Persistent Postoperative Pain Using the Numeric Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Arthroplasty Patients', 'description': 'Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients, and questionnaires will be administered to assess pain and stiffness.\n\nTotal Knee Arthroplasty: Patients will undergo total unilateral knee arthroplasty for osteoarthritis.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after date of surgery', 'description': 'Defined as numeric rating scale (NRS) pain score ≥4 with activity in the operated joint. A lower score is a better outcome. 0 is no pain, and 10 is worst pain imaginable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients lost to follow up'}, {'type': 'SECONDARY', 'title': 'Patients Who Experienced Postoperative Joint Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Arthroplasty Patients', 'description': 'Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients, and questionnaires will be administered to assess pain and stiffness.\n\nTotal Knee Arthroplasty: Patients will undergo total unilateral knee arthroplasty for osteoarthritis.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks after date of surgery', 'description': 'The number of patients that experienced postoperative joint stiffness, defined as ≤95 degrees range of motion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Knee Range of Motion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Arthroplasty Patients (Stiff)', 'description': 'Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients, and questionnaires will be administered to assess pain and stiffness.\n\nTotal Knee Arthroplasty: Patients will undergo total unilateral knee arthroplasty for osteoarthritis.\n\nStiffness was defined as ≤ 95° ROM measured with a goniometer at 6 weeks (± 2 weeks).'}, {'id': 'OG001', 'title': 'Total Knee Arthroplasty Patients (Non-Stiff)', 'description': 'Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients, and questionnaires will be administered to assess pain and stiffness.\n\nTotal Knee Arthroplasty: Patients will undergo total unilateral knee arthroplasty for osteoarthritis.\n\nStiffness was defined as ≤ 95° ROM measured with a goniometer at 6 weeks (± 2 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '115.3', 'spread': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after date of surgery', 'description': 'Range of motion at 6 weeks postoperative. Measured as flexion minus extension. Measured in degrees.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'some patients did not answer the questionnaire'}, {'type': 'SECONDARY', 'title': 'NRS Pain at Rest on POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 6 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 6 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day after surgery', 'description': 'NRS pain at rest on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'some lost to follow up'}, {'type': 'SECONDARY', 'title': 'NRS Pain With Movement on POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 6 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 6 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day after surgery', 'description': 'NRS pain with movement on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients lost to follow up or did not answer questionnaire.'}, {'type': 'SECONDARY', 'title': 'Worst NRS Pain on POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 6 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 6 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '6', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day after surgery', 'description': 'Worst NRS pain on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients lost to follow up or did not answer questionnaire.'}, {'type': 'SECONDARY', 'title': 'Least NRS Pain on POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 6 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 6 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day after surgery', 'description': 'Least numerical rating scale (NRS) pain on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients lost to follow up or did not answer questionnaire.'}, {'type': 'SECONDARY', 'title': 'NRS Pain at Rest on POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 6 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 6 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '3', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days after surgery', 'description': 'Numerical rating scale (NRS) pain at rest on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients lost to follow up or did not answer questionnaire.'}, {'type': 'SECONDARY', 'title': 'NRS Pain With Movement on POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 6 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 6 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days after surgery', 'description': 'Numerical rating scale (NRS) pain with movement on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Worst NRS Pain on POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 6 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 6 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days after surgery', 'description': 'Worst numerical rating scale (NRS) pain on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Least NRS Pain on POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 6 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 6 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days after surgery', 'description': 'Least numerical rating scale (NRS) pain on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients lost to follow up or did not answer questionnaire.'}, {'type': 'SECONDARY', 'title': 'NRS Pain at Rest 4 Weeks After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 6 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 6 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '2', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks after surgery', 'description': 'Numerical rating scale (NRS) pain at rest on 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients lost to follow up or did not answer questionnaire.'}, {'type': 'SECONDARY', 'title': 'NRS Pain With Movement 4 Weeks After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 6 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 6 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks after surgery', 'description': 'Numerical rating scale (NRS) pain with movement on 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients lost to follow up or did not answer questionnaire.'}, {'type': 'SECONDARY', 'title': 'Worst NRS Pain 4 Weeks After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 6 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 6 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks after surgery', 'description': 'Worst numerical rating scale (NRS) pain 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients lost to follow up or did not answer questionnaire.'}, {'type': 'SECONDARY', 'title': 'Least NRS Pain 4 Weeks After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 6 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 6 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks after surgery', 'description': 'Least numerical rating scale (NRS) pain 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients lost to follow up or did not answer questionnaire.'}, {'type': 'SECONDARY', 'title': 'NRS Pain at Rest 3 Months After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 6 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 6 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after surgery', 'description': 'Numerical rating scale (NRS) pain at rest 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients lost to follow up or did not answer questionnaire.'}, {'type': 'SECONDARY', 'title': 'NRS Pain With Movement 3 Months After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 3 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 3 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 3 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after surgery', 'description': 'Numerical rating scale (NRS) pain with movement 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.\n\nThe average NRS pain for all participants who completed the survey at 3 months is reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients lost to follow up or did not answer questionnaire.'}, {'type': 'SECONDARY', 'title': 'Worst NRS Pain 3 Months After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 3 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 3 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 3 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 3 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after date of surgery', 'description': 'Worst numerical rating scale (NRS) pain 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.\n\nThe average worst NRS pain for all participants who completed the survey at 3 months is reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients lost to follow up or did not answer questionnaire.'}, {'type': 'SECONDARY', 'title': 'Least NRS Pain 3 Months After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 3 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 3 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 3 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 3 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after date of surgery', 'description': 'Least numerical pain rating (NRS) pain 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.\n\nThe average least NRS pain for all participants who completed the survey at 3 months is reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients lost to follow up or did not answer questionnaire.'}, {'type': 'SECONDARY', 'title': 'NRS Pain at Rest 6 Months After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 6 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 6 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months after date of surgery', 'description': 'NRS pain at rest 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.\n\nThe average NRS pain at rest for all participants who completed the survey at 6 months is reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients lost to follow up or did not answer questionnaire.'}, {'type': 'SECONDARY', 'title': 'Least NRS Pain 6 Months After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 6 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 6 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months after date of surgery', 'description': 'Least NRS pain 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.\n\nThe average least NRS pain for all participants who completed the survey at 6 months is reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients lost to follow up or did not answer questionnaire.'}, {'type': 'SECONDARY', 'title': 'Worst NRS Pain 6 Months After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 6 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 6 months following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months after date of surgery', 'description': 'Least NRS pain 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.\n\nThe average worst NRS pain for all participants who completed the survey at 6 months is reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients lost to follow up or did not answer questionnaire.'}, {'type': 'SECONDARY', 'title': 'Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Arthroplasty Patients (Stiff)', 'description': 'Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients, and questionnaires will be administered to assess pain and stiffness.\n\nTotal Knee Arthroplasty: Patients will undergo total unilateral knee arthroplasty for osteoarthritis.\n\nStiffness was defined as ≤ 95° ROM measured with a goniometer at 6 weeks (± 2 weeks).'}, {'id': 'OG001', 'title': 'Total Knee Arthroplasty Patients (Non-Stiff)', 'description': 'Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients, and questionnaires will be administered to assess pain and stiffness.\n\nTotal Knee Arthroplasty: Patients will undergo total unilateral knee arthroplasty for osteoarthritis.\n\nStiffness was defined as ≤ 95° ROM measured with a goniometer at 6 weeks (± 2 weeks).'}], 'classes': [{'title': 'KOOS Symptoms 4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'spread': '11', 'groupId': 'OG000'}, {'value': '32', 'spread': '12', 'groupId': 'OG001'}]}]}, {'title': 'KOOS Quality of Life 4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'spread': '15', 'groupId': 'OG000'}, {'value': '20', 'spread': '17', 'groupId': 'OG001'}]}]}, {'title': 'KOOS Symptoms 3 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'spread': '14', 'groupId': 'OG000'}, {'value': '33', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': 'KOOS Quality of Life 3 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'spread': '26', 'groupId': 'OG000'}, {'value': '37', 'spread': '20', 'groupId': 'OG001'}]}]}, {'title': 'KOOS Symptoms 6 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'spread': '15', 'groupId': 'OG000'}, {'value': '34', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': 'KOOS Quality of Life 6 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'spread': '21', 'groupId': 'OG000'}, {'value': '48', 'spread': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks, 3 months, and 6 months after date of surgery', 'description': "The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A higher score is a better outcome.\n\nThe score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.\n\nAlthough collected at different timepoints, the average score for each participant is calculated and then the average score for all patients is reported.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was measured at three different timepoints (4 weeks, 3 months, and 6 months). Some participants could not be reached for follow-up at certain timepoints, therefore the number of patients analyzed for each timepoint differs.'}, {'type': 'SECONDARY', 'title': 'Postoperative painDETECT Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS Pain is >=4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is greater or equal to 4 on the numerical rating scale 6 months following surgery.'}, {'id': 'OG001', 'title': 'NRS Pain is NOT >4 With Activity 6 Months Post-op', 'description': 'Patients whose pain with activity is less than to 4 on the numerical rating scale 6 months following surgery.'}], 'classes': [{'title': '4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '7', 'spread': '4.3', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '7', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks, 3 months, and 6 months after date of surgery', 'description': 'PainDETECT is a 9-item self-report screening questionnaire developed to detect NeP in conditions like chronic low back pain. PD-Q measures 7 aspects of the quality of the pain experienced, the chronological pattern (time course), and whether or not the pain radiates.\n\nIt is scored from 0 to 38, with total scores of \\<12 considered = nociceptive pain, 13-18 = possible NeP, and \\>19 = \\>90% likelihood of NeP. A lower score is a better outcome.\n\nAlthough measured at multiple time points, the average score for each participant is analyzed, and then the average scores for all participants is calculated and reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was measured at three different timepoints (4 weeks, 3 months, and 6 months). Some participants could not be reached for follow-up at certain timepoints, therefore the number of patients analyzed for each timepoint differs.'}, {'type': 'SECONDARY', 'title': 'Types of Preoperative Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Arthroplasty Patients', 'description': 'Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients, and questionnaires will be administered to assess pain and stiffness.\n\nTotal Knee Arthroplasty: Patients will undergo total unilateral knee arthroplasty for osteoarthritis.'}], 'classes': [{'title': 'used statins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'used gabapentin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'used anticonvulsants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'used selective serotonin reuptake inhibitors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'used tricyclic antidepressants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'used serotonin-norepinephrine reuptake inhibitors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before surgery', 'description': 'Statin, gabapentinoid, anticonvulsant, selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant, serotonin norepinephrine reuptake inhibitor (SNRI), and opioid and non-opioid pain medications.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'some patients did not answer the questionnaire'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Total Knee Arthroplasty Patients', 'description': 'Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients, and questionnaires will be administered to assess pain and stiffness.\n\nTotal Knee Arthroplasty: Patients will undergo total unilateral knee arthroplasty for osteoarthritis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '179'}]}, {'type': 'POD 1 Follow up', 'comment': 'Participants who were successfully contacted for Post-operative day 1 follow up.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}]}, {'type': 'POD 2 Follow up', 'comment': 'Participants who were successfully contacted for post-operative day 2 follow up.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}]}, {'type': '4 Weeks Post-op', 'comment': 'Participants who were successfully contacted for 4 weeks post-operation follow up.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}]}, {'type': '6 Weeks Post-op', 'comment': 'Participants who were successfully contacted for 6 weeks post-operation follow up.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}]}, {'type': '3 Month Post-op', 'comment': 'Participants who were successfully contacted for 3 months post-operation follow up.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}]}, {'type': '6 Months Post-op', 'comment': 'Participants who were successfully contacted for 6 months post-operation follow up.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}]}, {'type': 'Stratified to "Stiff" Group', 'comment': 'After completing all study activities/follow up, patients were stratified to the "Stiff" group if they reported a certain score across all questionnaires.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'Stratified to "Non-stiff" Group', 'comment': 'After completing all study activities/follow up, patients were stratified to the "Non-stiff" group if they reported a certain score across all questionnaires.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Patients were found have meet criteria under the exclusion criterion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Knee Arthroplasty Patients (Stiff)', 'description': 'Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients, and questionnaires will be administered to assess pain and stiffness.\n\nTotal Knee Arthroplasty: Patients will undergo total unilateral knee arthroplasty for osteoarthritis.\n\nStiffness was defined as ≤ 95° ROM measured with a goniometer at 6 weeks (± 2 weeks).'}, {'id': 'BG001', 'title': 'Total Knee Arthroplasty Patients (Non-Stiff)', 'description': 'Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients, and questionnaires will be administered to assess pain and stiffness.\n\nTotal Knee Arthroplasty: Patients will undergo total unilateral knee arthroplasty for osteoarthritis.\n\nStiffness was defined as ≤ 95° ROM measured with a goniometer at 6 weeks (± 2 weeks).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.8', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '67.3', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '66.9', 'spread': '8.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}, {'title': 'Declined/Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-27', 'size': 257497, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-28T12:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, serum, and joint fluid aspirate samples will be collected and stored for analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-23', 'studyFirstSubmitDate': '2015-12-08', 'resultsFirstSubmitDate': '2022-05-10', 'studyFirstSubmitQcDate': '2015-12-09', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-07', 'studyFirstPostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of Persistent Postoperative Pain Using the Numeric Rating Scale (NRS)', 'timeFrame': '6 months after date of surgery', 'description': 'Defined as numeric rating scale (NRS) pain score ≥4 with activity in the operated joint. A lower score is a better outcome. 0 is no pain, and 10 is worst pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'Patients Who Experienced Postoperative Joint Stiffness', 'timeFrame': '6 weeks after date of surgery', 'description': 'The number of patients that experienced postoperative joint stiffness, defined as ≤95 degrees range of motion.'}, {'measure': 'Postoperative Knee Range of Motion', 'timeFrame': '6 weeks after date of surgery', 'description': 'Range of motion at 6 weeks postoperative. Measured as flexion minus extension. Measured in degrees.'}, {'measure': 'NRS Pain at Rest on POD1', 'timeFrame': '1 day after surgery', 'description': 'NRS pain at rest on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.'}, {'measure': 'NRS Pain With Movement on POD1', 'timeFrame': '1 day after surgery', 'description': 'NRS pain with movement on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.'}, {'measure': 'Worst NRS Pain on POD1', 'timeFrame': '1 day after surgery', 'description': 'Worst NRS pain on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.'}, {'measure': 'Least NRS Pain on POD1', 'timeFrame': '1 day after surgery', 'description': 'Least numerical rating scale (NRS) pain on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.'}, {'measure': 'NRS Pain at Rest on POD2', 'timeFrame': '2 days after surgery', 'description': 'Numerical rating scale (NRS) pain at rest on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.'}, {'measure': 'NRS Pain With Movement on POD2', 'timeFrame': '2 days after surgery', 'description': 'Numerical rating scale (NRS) pain with movement on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.'}, {'measure': 'Worst NRS Pain on POD2', 'timeFrame': '2 days after surgery', 'description': 'Worst numerical rating scale (NRS) pain on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.'}, {'measure': 'Least NRS Pain on POD2', 'timeFrame': '2 days after surgery', 'description': 'Least numerical rating scale (NRS) pain on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.'}, {'measure': 'NRS Pain at Rest 4 Weeks After Surgery', 'timeFrame': '4 weeks after surgery', 'description': 'Numerical rating scale (NRS) pain at rest on 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.'}, {'measure': 'NRS Pain With Movement 4 Weeks After Surgery', 'timeFrame': '4 weeks after surgery', 'description': 'Numerical rating scale (NRS) pain with movement on 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.'}, {'measure': 'Worst NRS Pain 4 Weeks After Surgery', 'timeFrame': '4 weeks after surgery', 'description': 'Worst numerical rating scale (NRS) pain 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.'}, {'measure': 'Least NRS Pain 4 Weeks After Surgery', 'timeFrame': '4 weeks after surgery', 'description': 'Least numerical rating scale (NRS) pain 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.'}, {'measure': 'NRS Pain at Rest 3 Months After Surgery', 'timeFrame': '3 months after surgery', 'description': 'Numerical rating scale (NRS) pain at rest 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.'}, {'measure': 'NRS Pain With Movement 3 Months After Surgery', 'timeFrame': '3 months after surgery', 'description': 'Numerical rating scale (NRS) pain with movement 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.\n\nThe average NRS pain for all participants who completed the survey at 3 months is reported.'}, {'measure': 'Worst NRS Pain 3 Months After Surgery', 'timeFrame': '3 months after date of surgery', 'description': 'Worst numerical rating scale (NRS) pain 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.\n\nThe average worst NRS pain for all participants who completed the survey at 3 months is reported.'}, {'measure': 'Least NRS Pain 3 Months After Surgery', 'timeFrame': '3 months after date of surgery', 'description': 'Least numerical pain rating (NRS) pain 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.\n\nThe average least NRS pain for all participants who completed the survey at 3 months is reported.'}, {'measure': 'NRS Pain at Rest 6 Months After Surgery', 'timeFrame': '6 months after date of surgery', 'description': 'NRS pain at rest 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.\n\nThe average NRS pain at rest for all participants who completed the survey at 6 months is reported.'}, {'measure': 'Least NRS Pain 6 Months After Surgery', 'timeFrame': '6 months after date of surgery', 'description': 'Least NRS pain 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.\n\nThe average least NRS pain for all participants who completed the survey at 6 months is reported.'}, {'measure': 'Worst NRS Pain 6 Months After Surgery', 'timeFrame': '6 months after date of surgery', 'description': 'Least NRS pain 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.\n\nThe average worst NRS pain for all participants who completed the survey at 6 months is reported.'}, {'measure': 'Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores', 'timeFrame': '4 weeks, 3 months, and 6 months after date of surgery', 'description': "The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A higher score is a better outcome.\n\nThe score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.\n\nAlthough collected at different timepoints, the average score for each participant is calculated and then the average score for all patients is reported."}, {'measure': 'Postoperative painDETECT Scores', 'timeFrame': '4 weeks, 3 months, and 6 months after date of surgery', 'description': 'PainDETECT is a 9-item self-report screening questionnaire developed to detect NeP in conditions like chronic low back pain. PD-Q measures 7 aspects of the quality of the pain experienced, the chronological pattern (time course), and whether or not the pain radiates.\n\nIt is scored from 0 to 38, with total scores of \\<12 considered = nociceptive pain, 13-18 = possible NeP, and \\>19 = \\>90% likelihood of NeP. A lower score is a better outcome.\n\nAlthough measured at multiple time points, the average score for each participant is analyzed, and then the average scores for all participants is calculated and reported.'}, {'measure': 'Types of Preoperative Medications', 'timeFrame': 'Before surgery', 'description': 'Statin, gabapentinoid, anticonvulsant, selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant, serotonin norepinephrine reuptake inhibitor (SNRI), and opioid and non-opioid pain medications.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cytokines'], 'conditions': ['Pain', 'Joint Stiffness']}, 'referencesModule': {'references': [{'pmid': '34921052', 'type': 'DERIVED', 'citation': 'Sideris A, Malahias MA, Birch G, Zhong H, Rotundo V, Like BJ, Otero M, Sculco PK, Kirksey M. Identification of biological risk factors for persistent postoperative pain after total knee arthroplasty. Reg Anesth Pain Med. 2022 Mar;47(3):161-166. doi: 10.1136/rapm-2021-102953. Epub 2021 Dec 17.'}]}, 'descriptionModule': {'briefSummary': 'Persistent pain and joint stiffness after surgery may interfere with recovery and adversely affect quality of life in up to 40% of patients who have undergone total knee arthroplasty. There is growing evidence that inflammation as well as other medical and psychological factors may be associated with osteoarthritis severity, progression, and associated pain severity. This study aims to identify clinical, biological, and psychological factors that contribute to and predict the development of these complications. Identification of such factors may allow us to target preventative measures to the patients at highest risk of persistent postoperative pain and joint stiffness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital for Special Surgery patients scheduled to undergo unilateral total knee arthroplasty under regional anesthesia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective primary unilateral total knee arthroplasty\n* Osteoarthritis with radiologic evidence of "severe narrowing" and/or "bone on bone" in the affected joint\n* Patients of surgeons who have agreed to participate in the study\n* Age \\> 18 years\n* American Society of Anesthesiologists (ASA) Physical Status 1-3\n* Regional anesthesia\n* Epidural patient-controlled analgesia (PCA) for postoperative pain\n* Adductor canal block for postoperative pain\n\nExclusion Criteria:\n\n* Contraindication to regional anesthesia, NSAIDs, dexamethasone or acetaminophen\n* Use of general anesthesia\n* History of \\>6 weeks of daily opioid use and/or any use of non-prescribed opioids\n* Preoperative oral steroid use in the past 6 months\n* Intra-articular steroid injection within one month of scheduled surgery in affected joint\n* Non-English speakers\n* Pre-existing diagnosis of rheumatic disease or autoimmune disease (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, Type I diabetes)\n* Peri-articular injections or infusions for postoperative pain\n* Diagnosis of crystalline arthropathy\n* Diagnosis of osteonecrosis\n* Active infection or use of antibiotics\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT02626533', 'briefTitle': 'Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis', 'orgStudyIdInfo': {'id': '2015-361'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Total knee arthroplasty patients', 'description': 'Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study.\n\nBlood and joint fluid samples will be obtained from patients. Pain type and severity will be assessed at baseline (enrollment), 4 weeks, 3 months, and 6 months postoperatively.', 'interventionNames': ['Procedure: Total Knee Arthroplasty']}], 'interventions': [{'name': 'Total Knee Arthroplasty', 'type': 'PROCEDURE', 'description': 'Patients will undergo total unilateral knee arthroplasty for osteoarthritis.', 'armGroupLabels': ['Total knee arthroplasty patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Meghan Kirksey, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgery, New York'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}