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The Role of Synovectomy in Pain Reduction Following Total Knee Arthroplasty

StatusRecruiting
PhaseNot applicable
Started2023-11-20
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 23 months later Dec 2025 → Dec 2027
See other at-risk trials from London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Amendment history

2026-09-23
critical
Primary completion pushed: 2025-12 → 2027-12
Completion pushed: 2026-12 → 2027-12
2025-03-13
minor
Study Status v3
Primary completion date2024-12→2025-12
Completion date2024-12→2026-12
2024-10-02
minor
Study Status, Oversight, Study Design, Arms and Interventions, Eligibility, Contacts/Locations, IPDSharing v2
Enrollment target62→300
InterventionsSynovectomy (Procedure)→Partial synovectomy (Procedure)
Eligibility criteria-8 characters
[...] Clinic at University Hospital Exclusion Criteria: Bilateral, second, uni-compartmental, or revision total knee arthroplasty Ost [...]
2024-02-28
notable
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-12→2024-12
Completion date2024-03→2024-12
Start dateestimated 2023-05→confirmed 2023-11-20
Eligibility criteria+6 characters
[...] ide, TNF inhibitors, etc.) - note: Gout is NOT an exclusion Joint injection (steroid or viscosupplement) within 12 weeks of Pre-Admission Clinic appointment date Cannot read, write, or understand English (printed instructi [...] follow up at routine standard of care post-operative visits Joint injection (steroid or viscosupplement) within 12 weeks of Pre-admission Clinic visit date
Secondary endpoints6 to 7 entries
Inflammation
2023-03-23
minor
Original filing
Osteoarthritis (OA) is the most common joint disease, causing severe pain due to joint inflammation (synovitis). While total knee arthroplasty (TKA) is commonly performed to reduce pain, 20% of patients are dissatisfied with their outcome post-surgery. This dissatisfaction is caused by persistent pain post-TKA due to synovitis that is not routinely removed during surgery. To address this problem, a synovectomy can be performed during TKA, which involves resecting the inflamed layer of tissue lining the joint, called the synovium, and its associated sensory nerve endings. Since the synovium will regenerate in the months post-surgery, synovectomy only transiently reduces pain after TKA. The proposed study will help ascertain the benefits and effects of synovectomy in patients who are more likely to experience poor satisfaction (driven mostly by pain) post-TKA. This study will include 62 patients undergoing TKA due to end-stage OA who have moderate to severe synovitis, as determined by ultrasound assessment. Patients will be randomized (1:1) to undergo a TKA with synovectomy or without synovectomy. Primary and secondary outcomes will be assessed through patient-reported levels of pain and function, results from physical performance tests, and quality of life (QOL) scores. These measures will be recorded pre- and post-surgery for comparison. Through demonstrating that synovectomy can at least transiently reduce pain post-TKA, this study will provide evidence for the development of medical therapies that target the synovium to slow its regrowth. This will be transformative for the long-term management of joint pain and synovitis post-surgery, thus significantly improving patients' overall QOL.
Trial Details
NCT Number NCT05800457
Lead Sponsor London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions Osteoarthritis, Knee
Enrollment 300 participants
Start Date 2023-11-20
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-22