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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 41
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
London Health Sciences Centre - University Hospital
RECRUITING
London
Contact Information
Primary
Lyndsay E Somerville, PhD
lyndsay.somerville@lhsc.on.ca
5196858500
Backup
Maharshi Nagda, MD
mnagda@uwo.ca
Time Frame
Start Date: 2023-11-20
Estimated Completion Date: 2026-12
Participants
Target number of participants: 300
Treatments
Experimental: Total knee replacement with partial synovectomy
Patients in this arm will undergo partial synovectomy during total knee replacement surgery.
No_intervention: Total knee replacement without partial synovectomy
Patients in this arm will not undergo partial synovectomy during total knee replacement surgery.
Sponsors
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

This content was sourced from clinicaltrials.gov

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