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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if removing the inflamed joint lining during knee replacement surgery can reduce pain for individuals with severe knee arthritis. Participants will undergo knee replacement either with or without this additional step, known as synovectomy, to assess its impact on pain and quality of life. The trial seeks individuals over 40 with severe knee arthritis and inflammation who are planning their first knee replacement surgery. As an unphased trial, it provides a unique opportunity to contribute to medical knowledge and potentially enhance future treatment options.

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 prior data suggests that synovectomy is safe for osteoarthritis patients undergoing total knee replacement?

Research has shown that synovectomy, the removal of inflamed tissue from a joint, is generally safe during knee replacement surgery. Studies have found that although synovectomy may lead to more blood loss and longer surgery time, it does not increase the risk of complications or the need for blood transfusions. Additionally, there is no added risk of pain or reduced function after surgery compared to having a knee replacement alone. For those considering joining a trial, past patients have tolerated the procedure well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about synovectomy as a treatment for osteoarthritis because it offers a potential enhancement to traditional total knee replacement surgeries. Unlike standard treatments that focus solely on replacing the joint, this approach involves partially removing inflamed synovial tissue during the procedure. This could help reduce inflammation and improve joint function, leading to better long-term outcomes for patients. By addressing both the joint structure and the inflammation source, synovectomy may offer a more comprehensive solution to knee osteoarthritis.

What evidence suggests that synovectomy is effective for reducing pain in osteoarthritis?

This trial will compare total knee replacement with and without partial synovectomy. Research has shown that removing inflamed tissue during knee replacement surgery, known as synovectomy, doesn't significantly improve pain relief or overall satisfaction. Studies have found that it might lead to more blood loss and longer surgery times without providing lasting benefits for pain or knee movement. Specifically, knees that underwent this procedure showed less flexibility and worse pain scores. Current evidence suggests that synovectomy doesn't improve long-term outcomes for osteoarthritis patients undergoing knee replacement surgery. While it temporarily removes inflamed tissue, it doesn't seem to offer clear long-term benefits. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 over 40 and have been diagnosed with knee osteoarthritis.

Exclusion Criteria

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

I am having or have had a knee replacement surgery.

Cannot read, write, or understand English (printed instructions are provided in English only)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10106132/

Long-term results of synovectomy in total knee arthroplasty Synovectomy in conjunction with TKA for primary OA does not seem to provide any benefit regarding postoperative pain, ROM, and satisfaction during a 10-year ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8601306/

Should synovectomy be performed during total knee ... Some researchers have suggested that synovectomy increases blood loss and operation time and has no beneficial effect on postoperative pain or ...

3. link.springer.com link.springer.com/article/10.1007/s00264-025-06441-3

Is synovectomy still of benefit today in total knee ... Knees undergoing synovectomy during primary TKA exhibited reduced knee flexion, inferior Knee Society pain scores, and higher complication rates.

4. journals.lww.com journals.lww.com/md-journal/fulltext/2021/11190/should_synovectomy_be_performed_during_total_knee.39.aspx

Should synovectomy be performed during total knee... Some researchers have suggested that synovectomy increases blood loss and operation time and has no beneficial effect on postoperative pain or ...

5. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-018-0752-y

The efficacy of synovectomy for total knee arthroplasty: a meta ... In conclusion, current evidence indicates that synovectomy has no effects on the final clinical outcomes for OA patients undergoing TKA. It will ...

6. aetna.com aetna.com/cpb/medical/data/600_699/0673.html

Knee Arthroscopy / Osteoarthritis of the Knee Functional scores improved from 42 points pre-operatively to 70 points at 1-year. Moreover, 13 (25 %) patients had an excellent outcome with pain abolished and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6716854/

Should synovectomy be performed in primary total knee ... However, synovectomy is safe. It has no effect on postoperative pain and function, complications, and blood transfusion rate. While these ...

8. mednexus.org mednexus.org/doi/10.1097/CM9.0000000000002205

Long-term results of synovectomy in total knee arthroplasty This study was aimed at assessing pain, function, and complications in patients undergoing synovectomy during TKA for osteoarthritis (OA) at ...