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Synovectomy during total knee arthroplasty: a pilot single-centre randomised controlled trial
Kenneth S Rankin1, Jayasree Ramaskandhan1, Michelle Bardgett1
11Musculoskeletal Department, Freeman Hospital, High Heaton, Newcastle upon Tyne, NE7 7DN UK.
Pilot and Feasibility Studies
|August 29, 2018
Summary
This pilot study shows that recruiting patients with inflamed synovium for a synovectomy during total knee arthroplasty (TKA) is feasible and safe. Further multi-center trials are needed to confirm if this improves patient outcomes.
Area of Science:
- Orthopedic Surgery
- Rheumatology
- Clinical Trials
Background:
- Total knee arthroplasty (TKA) is effective for knee osteoarthritis (OA), but patient dissatisfaction occurs in up to 20%.
- Residual synovium inflammation may contribute to dissatisfaction after TKA.
- This study investigates synovectomy during TKA for inflamed synovium.
Purpose of the Study:
- To conduct the first randomized controlled trial (RCT) of synovectomy during TKA in patients with macroscopically inflamed synovium.
- To assess recruitment rates, protocol adherence, and safety outcomes (hemoglobin decrease, adverse events).
- To collect patient-reported outcome data.
Main Methods:
- A single-center pilot RCT was performed.
- Patients with macroscopically inflamed synovium were randomized to synovectomy or a control group.
- Feasibility was determined by enrollment and follow-up completeness; safety was assessed via hemoglobin and adverse events.
Main Results:
- 360 patients screened; 100 eligible, 54 enrolled, 40 randomized.
- 100% 12-month follow-up achieved, indicating good protocol adherence.
- No significant differences in adverse events or hemoglobin decrease, demonstrating acceptable safety.
Conclusions:
- Reliable recruitment and safe performance of synovectomy during TKA are possible for patients with inflamed synovium.
- A large number of patients require screening, necessitating a multi-center trial.
- Future multi-center trials are needed to determine if routine synovectomy improves outcomes.
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