Clinical trial NCT05800457: The Role of Synovectomy in Pain Reduction Following Total Knee Arthroplasty
Official title: The Role of Synovectomy in Pain Reduction Among Osteoarthritis Patients Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 300
Sex: ALL
Minimum age (years): 41
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


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

Primary outcomes:
measure: Patients' self-reported level of pain
timeFrame: 12 weeks post-surgery
Secondary outcomes:
measure: Joint function - 30-Second Sit to Stand Test
timeFrame: 6, 12, 18, and 24 weeks post-surgery
measure: Joint function - Timed Up and Go Test
timeFrame: 6, 12, 18, and 24 weeks post-surgery
measure: Patients' self-reported quality of life
timeFrame: 6, 12, 18, and 24 weeks post-surgery
measure: Symptoms sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 6, 12, 18, and 24 weeks post-surgery
measure: Activities of daily living sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 6, 12, 18, and 24 weeks post-surgery
measure: Knee-related quality of life sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 6, 12, 18, and 24 weeks post-surgery
measure: Inflammation
timeFrame: Ultrasound: Before surgery, 3 and 6 months post-surgery, Samples: Intra-operatively
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
Study officials:
References: