The Role of Synovectomy in Pain Reduction Following Total Knee Arthroplasty

NCT ID: NCT05800457

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-20
• Study Completion Date: 2026-12-31

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Total knee replacement with partial synovectomy

Patients in this arm will undergo partial synovectomy during total knee replacement surgery.

Group Type: EXPERIMENTAL

Partial synovectomy

Intervention Type: PROCEDURE

Patients in the intervention group will undergo partial synovectomy during total knee replacement surgery

Total knee replacement without partial synovectomy

Patients in this arm will not undergo partial synovectomy during total knee replacement surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Partial synovectomy

Patients in the intervention group will undergo partial synovectomy during total knee replacement surgery

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 41 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Brent Lanting

Orthopaedic Surgeon, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

London Health Sciences Centre - University Hospital

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Lyndsay E Somerville, PhD

Role: CONTACT

lyndsay.somerville@lhsc.on.ca

5196858500 ext. 36645

Maharshi Nagda, MD

Role: CONTACT

mnagda@uwo.ca

Facility Contacts

Brent Lanting, M.D.

Role: primary

Brent.Lanting@lhsc.on.ca

519-685-8500 ext. 33335

Other Identifiers

12994

Identifier Type: -

Identifier Source: org_study_id