The Role of Synovectomy in Pain Reduction Following Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05800457
• Other study ID #: 12994
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 41 Years to 80 Years

Eligibility

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, second, 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Synovectomy
Patients in the intervention group will undergo synovectomy during total knee replacement surgery

Locations

Country	Name	City	State
Canada	London Health Sciences Centre - University Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Joint function - 30-Second Sit to Stand Test	The 30-Second Sit to Stand Test, which assesses leg strength and endurance in older adults, requires patients to complete as many full stands from the chair as possible in a 30-second time period. The number of full stands completed is compared to values that correspond to the patient's age group to determine their level of performance (a higher number is better).	6, 12, 18, and 24 weeks post-surgery
Secondary	Joint function - Timed Up and Go Test	To begin the Timed Up and Go Test, patients will be seated in a chair. They will be signalled to stand up, walk to a line positioned three meters away from the chair, and walk back at a normal pace. Patients will then be instructed to return to their seated position. Patients' time, in seconds, will be recorded. Taking a longer time to perform this test indicates that the patient is less mobile, has a poorer sense of balance, and is at a higher risk of falling (taking a longer time is worse).	6, 12, 18, and 24 weeks post-surgery
Secondary	Patients' self-reported quality of life	Quality of life will be evaluated using the European Quality of Life Five-Dimension (EQ-5D). The EQ-5D measures generic quality of life and consists of domains concluding mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Scores range from zero to one, with higher scores indicating a better quality of life. This tool has strong test re-test reliability and cross-sectional construct validity in patients with knee OA.	6, 12, 18, and 24 weeks post-surgery
Secondary	Symptoms sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS)	This sub-scale contains seven items. Each question on the KOOS 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.	6, 12, 18, and 24 weeks post-surgery
Secondary	Activities of daily living sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS)	This sub-scale contains 17 items. Each question on the KOOS 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.	6, 12, 18, and 24 weeks post-surgery
Secondary	Knee-related quality of life sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS)	This sub-scale contains four items. Each question on the KOOS 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.	6, 12, 18, and 24 weeks post-surgery
Secondary	Inflammation	This will be measured through ultrasound scans pre- and post-surgery and by collecting synovial fluid and tissue samples intra-operatively.	Ultrasound: Before surgery, 3 and 6 months post-surgery, Samples: Intra-operatively