Synovectomy for Osteoarthritis

Overseen By Maharshi Nagda, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lawson Health Research Institute

Must not be taking: Dmards

Disqualifiers: Bilateral TKA, Genetic syndromes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using disease-modifying anti-rheumatic drugs (like methotrexate or TNF inhibitors), you cannot participate. Also, you should not have had a joint injection within 12 weeks before your clinic appointment.

What data supports the effectiveness of the treatment Synovectomy for Osteoarthritis?

Some studies suggest that synovectomy, when performed during knee surgery, may help reduce pain and improve knee function in patients with osteoarthritis. Additionally, synovectomy has shown benefits in reducing pain and swelling in patients with rheumatoid arthritis, which might indicate potential benefits for osteoarthritis as well. ^{1 2 3 4 5}

Is synovectomy generally safe for humans?

The research indicates that orthopaedic surgeries, including those for osteoarthritis, generally have low rates of serious complications. However, like any surgery, there are risks of adverse events, but these are typically not common. ^{6 7 8 9 10}

How does the treatment synovectomy differ from other treatments for osteoarthritis?

Synovectomy is a surgical treatment that involves removing the inflamed synovial tissue (the lining of the joint) and can be performed using minimally invasive arthroscopic techniques, which reduces recovery time and pain compared to traditional open surgery. This approach is unique because it directly targets the synovial tissue, potentially providing pain relief and improved joint function, especially when performed early before significant joint damage occurs. ^{1 4 11 12 13}

What is the purpose of this trial?

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

This trial is for men and women over 40 with knee osteoarthritis, scheduled for their first total knee replacement. They must have moderate to severe joint inflammation as shown by ultrasound. Participants are being accepted from a specific hospital's Pre-Admission Clinic.

Inclusion Criteria

Referred to the Pre-Admission Clinic at University Hospital

My ultrasound shows I have moderate to severe swelling in my joints.

I am scheduled for my first knee replacement surgery on one side.

Exclusion Criteria

I understand instructions and do not have severe cognitive or psychological issues.

I am having or have had a knee replacement surgery.

I have not had a joint injection in the last 12 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo total knee arthroplasty with or without synovectomy

1 day

1 visit (in-person)

Post-surgery Follow-up

Participants are monitored for pain, joint function, and quality of life

24 weeks

Multiple visits at 6, 12, 18, and 24 weeks post-surgery

Long-term Follow-up

Participants are monitored for inflammation through ultrasound scans

6 months

Visits at 3 and 6 months post-surgery

Treatment Details

Interventions

• Synovectomy

Trial Overview The study tests if removing the inflamed tissue lining during knee replacement surgery (synovectomy) can reduce pain after the operation. Patients will be randomly assigned to receive either standard surgery or surgery with synovectomy, and their pain levels and quality of life will be compared before and after.

Participant Groups

Group I: Total knee replacement with partial synovectomy Experimental Treatment 1 Intervention

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

Group II: Total knee replacement without partial synovectomy Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

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

Lead Sponsor

Trials

686

Recruited

427,000+

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

Lead Sponsor

Trials

678

Recruited

421,000+

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

Lead Sponsor

Trials

668

Recruited

424,000+

Findings from Research

In a study of 2,146 patients undergoing elective knee, hip, and spine surgeries for degenerative conditions, the overall adverse event rate was 27%, with spinal surgeries having the highest rate of severe adverse events.

Key risk factors for adverse events included increasing age, male sex, longer operative duration, longer hospital stays, and undergoing revision surgery, highlighting the need for careful patient assessment and procedural efficiency improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated with Adverse Events in Inpatient Elective Spine, Knee, and Hip Orthopaedic Surgery. Millstone, DB., Perruccio, AV., Badley, EM., et al.[2017]

In a study analyzing 6,029 patient claims after orthopedic surgery in Sweden, 55% were identified as adverse events, with hospital-acquired infections and sepsis being the most common, accounting for 22% of these events.

Spinal surgeries, particularly decompression of the spinal cord and nerve roots, had the highest rate of adverse events, with 21.4% of affected patients experiencing serious disability or death, highlighting the significant risks associated with these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What can we learn from patient claims? - A retrospective analysis of incidence and patterns of adverse events after orthopaedic procedures in Sweden. Ohrn, A., Elfström, J., Tropp, H., et al.[2021]

In a study of 143 patients with rheumatoid arthritis (RA) and osteoarthritis (OA), 35.7% experienced adverse drug events (ADEs), highlighting the commonality of these events in patients taking medications for these conditions.

Most ADEs were linked to disease-modifying anti-rheumatic drugs (59.4%) and non-steroidal anti-inflammatory drugs (14.5%), with 44.1% of the ADEs deemed preventable, indicating a need for better monitoring and management of drug safety in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events in rheumatoid arthritis and osteoarthritis ambulatory patients. Tragulpiankit, P., Chulavatnatol, S., Rerkpattanapipat, T., et al.[2012]

References

1. United States pubmed.ncbi.nlm.nih.gov

Should synovectomy be performed during total knee arthroplasty for knee osteoarthritis: A protocol for systematic review and meta-analysis. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

Multicenter evaluation of synovectomy in the treatment of rheumatoid arthritis. Report of results at the end of five years. [2017]

3. China pubmed.ncbi.nlm.nih.gov

[Long-term follow-up results of synovectomy for rheumatoid knee]. [2017]

4. Germany pubmed.ncbi.nlm.nih.gov

The effect of total synovectomy in total knee arthroplasty: a prospective randomized controlled study. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Arthroscopic synovectomy: a prospective study. [2006]

6. United States pubmed.ncbi.nlm.nih.gov

Factors Associated with Adverse Events in Inpatient Elective Spine, Knee, and Hip Orthopaedic Surgery. [2017]

7. England pubmed.ncbi.nlm.nih.gov

What can we learn from patient claims? - A retrospective analysis of incidence and patterns of adverse events after orthopaedic procedures in Sweden. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Low rates of serious complications and further procedures following surgery for base of thumb osteoarthritis: analysis of a national cohort of 43 076 surgeries. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Adverse drug events in rheumatoid arthritis and osteoarthritis ambulatory patients. [2012]

10. United States pubmed.ncbi.nlm.nih.gov

The Safety of Hand and Upper-Extremity Surgical Procedures at a Freestanding Ambulatory Surgery Center: A Review of 28,737 Cases. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Synovial proliferative disorders: role of synovectomy. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

[Indications and types of synovectomy]. [2017]

13. Germany pubmed.ncbi.nlm.nih.gov

[Arthroscopic surgical synovectomy of the knee joint (indications, technic, follow-up results)]. [2017]