Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-03-01 @ 8:13 PM
Study NCT ID:
NCT06553118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-15
First Post:
2024-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Central Sensitivity on Pain and Functional Status After Total Knee Joint Replacement Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-02-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2024-08-10', 'studyFirstSubmitQcDate': '2024-08-10', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee pain', 'timeFrame': 'Preoperative, 1 month postoperative and 3 months postoperative', 'description': 'Knee pain will be assessed with numerical rating scale, where the patients rate their pain on a scale from 0 to 10 where 0 means no pain and 10 means the most severe pain they can imagine.'}], 'secondaryOutcomes': [{'measure': 'Functional Status', 'timeFrame': 'Preoperative, 1 month postoperative and 3 months postoperative', 'description': 'Functionality of the patients will be assessed with WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index). Responses are typically rated on a scale from 0 (none) to 4 (extreme). Higher scores indicate greater impairment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Sensitisation', 'Postoperative Pain', 'Arthritis']}, 'descriptionModule': {'briefSummary': 'The study is a prospective observational study designed to determine the effects of central sensitization on pain and functional status of patients before and after total knee joint replacement surgery.\n\nThe aim of this study is to evaluate whether there is a difference in preoperative and postoperative pain and functional status between patients with and without central sensitization with knee osteoarthritis.\n\nWhen the literature was reviewed, it was seen that central sensitization was one of the important mechanisms that caused pain in knee osteoarthritis, and it was determined that this had negative consequences in terms of postoperative pain and improvement in functional status. In this study, the effect of central sensitization on the results will be investigated by evaluating pain and functional status before and after knee total joint prosthesis in two groups of knee osteoarthritis patients, with and without central sensitization, and by comparing the groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of patients who were planned to have total knee arthroplasty for primary knee osteoarthritis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of primary knee osteoarthritis\n* Planning for total joint replacement surgery for the knee\n* Being between the ages of 60-75\n\nExclusion Criteria:\n\n* Having secondary knee osteoarthritis\n* Planning for knee total joint prosthesis revision\n* Having uncontrolled systemic disease (such as diabetes mellitus, hypertension, thyroid disease)\n* Having neuromuscular disease\n* Having a body mass index over 40'}, 'identificationModule': {'nctId': 'NCT06553118', 'briefTitle': 'Evaluation of the Effect of Central Sensitivity on Pain and Functional Status After Total Knee Joint Replacement Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Evaluation of the Effect of Central Sensitivity on Pain and Functional Status After Total Knee Joint Replacement Surgery', 'orgStudyIdInfo': {'id': '2024/1010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Central Sensitization Group', 'description': 'Patients with central sensitization', 'interventionNames': ['Procedure: Total knee arthroplasty']}, {'label': 'Non-sensitized Group', 'description': 'Patients without central sensitization', 'interventionNames': ['Procedure: Total knee arthroplasty']}], 'interventions': [{'name': 'Total knee arthroplasty', 'type': 'PROCEDURE', 'description': 'Patients already admitted for total knee arthroplasty for knee osteoarthritis will have the procedure as planned', 'armGroupLabels': ['Central Sensitization Group', 'Non-sensitized Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Fatma Merih Akpınar', 'role': 'CONTACT', 'email': 'merihcaliskan@gmail.com', 'phone': '+905333558843'}, {'name': 'Berk Korkut', 'role': 'CONTACT', 'email': 'berkkorkut@windowslive.com', 'phone': '+905305202866'}], 'overallOfficials': [{'name': 'Fatma Merih Akpınar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Fatma Merih Akpınar', 'investigatorAffiliation': 'Istanbul University'}}}}