Actively Recruiting
The Role of Synovectomy in Pain Reduction Following Total Knee Arthroplasty
Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2025-03-17
300
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Role of Synovectomy in Pain Reduction Following Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females over the age of 40 diagnosed with knee osteoarthritis
- Scheduled for first unilateral total knee arthroplasty
- Moderate to severe (at least grade two) synovitis and synovial hyperplasia, as determined by ultrasound assessment
- Referred to the Pre-Admission Clinic at University Hospital
You will not qualify if you...
- Bilateral, uni-compartmental, or revision total knee arthroplasty
- Osteoarthritis due to genetic syndromes such as Ehlers-Danlos Syndrome
- Known inflammatory arthropathy, other rheumatic diseases, or current use of disease-modifying anti-rheumatic drugs (e.g., methotrexate, hydroxychloroquine, sulfasalazine, leflunomide, TNF inhibitors)
- Joint injection (steroid or viscosupplement) within 12 weeks of Pre-Admission Clinic appointment
- Inability to read, write, or understand English
- Any factors preventing attendance at follow-up appointments (e.g., socio-economic issues, distance, no phone access)
- Cognitive impairment or psychological problems affecting understanding of instructions
- Unable to attend routine post-operative follow-up visits
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
London Health Sciences Centre - University Hospital
London, Ontario, Canada, N6A 5W9
Actively Recruiting
Research Team
L
Lyndsay E Somerville, PhD
CONTACT
M
Maharshi Nagda, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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