The Role of Synovectomy in Pain Reduction Following Total Knee Arthroplasty

NCT05800457 | Recruiting

• 1 other identifier: 12994
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Patients' self-reported level of pain

  Pain will be measured using the pain sub-scale (nine items) of the Knee injury and Osteoarthritis Outcome Score (KOOS). Each question on the KOOS is a self-administered questionnaire is assigned a score from zero (no problems) to four (extreme problems) using a five-point Likert scale. The average of each sub-scale is calculated independently. Sub-scale scores range from zero (minimum), indicating severe knee problems, to 100 (maximum), indicating no knee problems (therefore, a higher score is better). The KOOS has demonstrated face validity and construct validity, as well as excellent test-retest reliability for each domain. It has also shown to be responsive to change in patients with knee OA.

  12 weeks post-surgery

Secondary Outcomes (7)

• Joint function - 30-Second Sit to Stand Test

  6, 12, 18, and 24 weeks post-surgery

• Joint function - Timed Up and Go Test

  6, 12, 18, and 24 weeks post-surgery

• Patients' self-reported quality of life

  6, 12, 18, and 24 weeks post-surgery

• Symptoms sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS)

  6, 12, 18, and 24 weeks post-surgery

• Activities of daily living sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS)

  6, 12, 18, and 24 weeks post-surgery

Study Arms (2)

Total knee replacement with partial synovectomy

EXPERIMENTAL

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

Procedure: Partial synovectomy

Total knee replacement without partial synovectomy

NO INTERVENTION

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

Interventions

Partial synovectomy PROCEDURE

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

Total knee replacement with partial synovectomy

Eligibility Criteria

• Age: 41 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Bilateral, uni-compartmental, or revision total knee arthroplasty
• Osteoarthritis due to genetic syndromes (e.g., Ehlers-Danlos Syndrome, etc.)
• 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

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5W9, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Lyndsay E Somerville, PhD

CONTACT

5196858500; lyndsay.somerville@lhsc.on.ca

Maharshi Nagda, MD

CONTACT

mnagda@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon, Principal Investigator

Study Record Dates

• First Submitted: March 4, 2023
• First Posted: April 5, 2023
• Study Start: November 20, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)