Osteoarthritis, KneeNCT05800457
The Role of Synovectomy in Pain Reduction Following Total Knee Arthroplasty
A study testing Partial synovectomy in people with Osteoarthritis, Knee, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 41 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Partial synovectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 20 Nov 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Bilateral, uni-compartmental, or revision total knee arthroplasty
- Osteoarthritis due to genetic syndromes (e.g., Ehlers-Danlos Syndrome, etc.)
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maharshi Nagda, MD contact
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5W9
Brent Lanting, M.D., 519-685-8500 ext. 33335, Brent.Lanting@lhsc.on.ca
About this study
Official title: The Role of Synovectomy in Pain Reduction Among Osteoarthritis Patients Following Total Knee Arthroplasty
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
- Being tested
- Partial synovectomy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial synovectomyProcedure or surgery
Patients in the intervention group will undergo partial synovectomy during total knee replacement surgery
| Study group | Role | What they receive |
|---|---|---|
| Total knee replacement with partial synovectomy | Experimental | Patients in this arm will undergo partial synovectomy during total knee replacement surgery. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks post-surgery
Secondary outcomes (7)
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).
Measured: 6, 12, 18, and 24 weeks post-surgery
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).
Measured: 6, 12, 18, and 24 weeks post-surgery
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.
Measured: 6, 12, 18, and 24 weeks post-surgery
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.
Measured: 6, 12, 18, and 24 weeks post-surgery
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.
Measured: 6, 12, 18, and 24 weeks post-surgery
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.
Measured: 6, 12, 18, and 24 weeks post-surgery
Inflammation
This will be measured through ultrasound scans pre- and post-surgery and by collecting synovial fluid and tissue samples intra-operatively.
Measured: Ultrasound: Before surgery, 3 and 6 months post-surgery, Samples: Intra-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start20 Nov 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brent Lanting, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800457
- Sponsor's protocol ID
- 12994
- Status last verified
- Sep 2026
- First submitted
- 4 Mar 2023
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Synovectomy in Pain Reduction Among Osteoarthritis Patients Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05800457
- Acronym / sponsor ID
- 12994
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total knee replacement with partial synovectomy | Experimental | Procedure: Partial synovectomyPatients in this arm will undergo partial synovectomy during total knee replacement surgery. |
| Total knee replacement without partial synovectomy | No intervention | –Patients in this arm will not undergo partial synovectomy during total knee replacement surgery. |
Who may qualify
- Ages
- 41 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Bilateral, uni-compartmental, or revision total knee arthroplasty
- Osteoarthritis due to genetic syndromes (e.g., Ehlers-Danlos Syndrome, etc.)
- 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
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial synovectomyPatients in the intervention group will undergo partial synovectomy during total knee replacement surgery | Procedure or surgery | Total knee replacement with partial synovectomy |
Primary outcome
Patients' self-reported level of pain
Time frame: 12 weeks post-surgery
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.
7 secondary outcomes
Joint function - 30-Second Sit to Stand Test
Time frame: 6, 12, 18, and 24 weeks post-surgery
Joint function - Timed Up and Go Test
Time frame: 6, 12, 18, and 24 weeks post-surgery
Patients' self-reported quality of life
Time frame: 6, 12, 18, and 24 weeks post-surgery
Symptoms sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 6, 12, 18, and 24 weeks post-surgery
Activities of daily living sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 6, 12, 18, and 24 weeks post-surgery
Knee-related quality of life sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 6, 12, 18, and 24 weeks post-surgery
Inflammation
Time frame: Ultrasound: Before surgery, 3 and 6 months post-surgery, Samples: Intra-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maharshi Nagda, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial synovectomy in people with Osteoarthritis, Knee, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lyndsay E Somerville, PhD (5196858500 ext. 36645, lyndsay.somerville@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' self-reported level of pain (time frame: 12 weeks post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.