The Role of Synovectomy in Pain Reduction Following Total Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Partial synovectomy.
- Who it may be relevant to
- Registry conditions: Osteoarthritis, Knee. Basic parameters: 41 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Role of Synovectomy in Pain Reduction Among Osteoarthritis Patients Following Total Knee Arthroplasty
Overview
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.
Interventions
- Procedure Partial synovectomy
Patients in the intervention group will undergo partial synovectomy during total knee replacement surgery
Primary outcome measures
- Patients' self-reported level of pain [Time frame: 12 weeks post-surgery]
Secondary outcome measures (7)
- Joint function - 30-Second Sit to Stand Test [Time frame: 6, 12, 18, and 24 weeks post-surgery]
- Joint function - Timed Up and Go Test [Time frame: 6, 12, 18, and 24 weeks post-surgery]
- Patients' self-reported quality of life [Time frame: 6, 12, 18, and 24 weeks post-surgery]
- Symptoms sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS) [Time frame: 6, 12, 18, and 24 weeks post-surgery]
- Activities of daily living sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS) [Time frame: 6, 12, 18, and 24 weeks post-surgery]
- Knee-related quality of life sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS) [Time frame: 6, 12, 18, and 24 weeks post-surgery]
- Inflammation [Time frame: Ultrasound: Before surgery, 3 and 6 months post-surgery, Samples: Intra-operatively]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Bilateral, uni-compartmental, or revision total knee arthroplasty
- Osteoarthritis due to genetic syndromes (e.g., Ehlers-Danlos Syndrome, etc.)
- 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
- Joint injection (steroid or viscosupplement) within 12 weeks of Pre-Admission Clinic appointment date
- Cannot read, write, or understand English (printed instructions are provided in English only)
- Any factors precluding patients from attending follow-up appointments (e.g., socio-economic limitations, distance from clinic, no access to home/cell phone, etc.).
- Cognitive impairment or psychological problems that preclude the ability to understand instructions
- Not able to follow up at routine standard of care post-operative visits
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Canada · 1 center
- London Health Sciences Centre - University Hospital — London
Identifiers
NCT: NCT05800457 · 12994