Examining the impact of synovectomy on pain relief after knee replacement surgery

The Role of Synovectomy in Pain Reduction Among Osteoarthritis Patients Following Total Knee Arthroplasty

This study is testing if removing inflamed tissue during knee replacement surgery can help people with osteoarthritis feel less pain and be happier with their results.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 41 Years to 80 Years
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 1 site (London, Ontario)
• Trial ID: NCT05800457 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of performing a synovectomy during total knee arthroplasty (TKA) for patients suffering from osteoarthritis and moderate to severe synovitis. The procedure involves removing the inflamed synovial tissue to potentially reduce post-surgical pain and improve patient satisfaction. By including 62 patients scheduled for their first unilateral TKA, the study aims to assess the short-term benefits of this intervention. The outcomes will help determine if synovectomy can lead to better pain management and overall satisfaction in patients who are likely to experience dissatisfaction after TKA.

Who should consider this trial

Good fit: Ideal candidates are individuals over 40 years old with knee osteoarthritis and moderate to severe synovitis scheduled for their first unilateral TKA.

Not a fit: Patients with bilateral or revision knee surgeries, inflammatory arthropathies, or those who cannot understand English may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve pain management and satisfaction for patients undergoing knee replacement surgery.

How similar studies have performed: While the specific approach of synovectomy during TKA is less commonly studied, similar interventions targeting synovitis have shown promise in improving outcomes in other contexts.

Eligibility criteria

Inclusion Criteria:

1. Males or females over the age of 40 diagnosed with knee osteoarthritis
2. Scheduled for first unilateral total knee arthroplasty
3. Moderate to severe (at least grade two) synovitis and synovial hyperplasia, as determined by ultrasound assessment
4. Referred to the Pre-Admission Clinic at University Hospital

Exclusion Criteria:

1. Bilateral, uni-compartmental, or revision total knee arthroplasty
2. Osteoarthritis due to genetic syndromes (e.g., Ehlers-Danlos Syndrome, etc.)
3. Known inflammatory arthropathy, another rheumatic disease, or disease-modifying anti-rheumatic drug (DMARD) use (e.g. methotrexate, hydroxychloroquine, sulfasalazine, leflunomide, TNF inhibitors, etc.) - note: Gout is NOT an exclusion
4. Joint injection (steroid or viscosupplement) within 12 weeks of Pre-Admission Clinic appointment date
5. Cannot read, write, or understand English (printed instructions are provided in English only)
6. Any factors precluding patients from attending follow-up appointments (e.g., socio-economic limitations, distance from clinic, no access to home/cell phone, etc.).
7. Cognitive impairment or psychological problems that preclude the ability to understand instructions
8. Not able to follow up at routine standard of care post-operative visits

Where this trial is running

London, Ontario

• London Health Sciences Centre - University Hospital — London, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Lyndsay E Somerville, PhD

Conditions Osteoarthritis, Knee