Osteoarthritis, KneePhase 4CoMeTNCT04641351
Corticosteroid Meniscectomy Randomized Trial
A Phase 4 study of Osteoarthritis, Knee and Meniscus Tear, run by The Cleveland Clinic at 2 sites in United States.
Trial summary
Synovitis has an important role in the symptoms and progression of Osteoarthritis (OA). Inflamed synovium has been associated with both increased symptoms and increased progression in OA patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Meniscus Tear, Meniscus; Degeneration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 May 2021to 1 Aug 2027
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 40 and older
- Scheduled for APM with enrolling surgeon
- Arthroscopic evidence of structural OA including at least one surface with grade 2 chondral change
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Who cannot join
- Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to inseminate a partner or donate sperm
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Known or suspected hypersensitivity to Zilretta (or component of Zilretta) or triamcinolone acetonide
- Kellgren and Lawrence Grade IV (severe OA; arthroplasty is typically preferred over APM in this setting)
- Injection with corticosteroid into affected knee in past 12 weeks
- Injection with platelet rich plasma into affected knee in past 12 weeks
Show all 11Show fewer
- Injection with hyaluronic acid into affected knee in past 24 weeks
- Plan for cartilage resurfacing procedure (microfracture, autologous chondrocyte implantation, osteochondral autograft or allograft), ligament reconstruction or other open procedure
- Bilateral surgery
- Unable to undergo MRI due to implanted medical device, aneurysm clamp, metal fragments in eye, etc.
- Absence of at least one area of grade 2 chondral change on diagnostic arthroscopy (patients without structural OA are excluded)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bringham and Women's Hospital
Boston, Massachusetts, 02115
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
About this study
Official title: Injection After Arthroscopic Partial Meniscectomy
Synovitis has an important role in the symptoms and progression of Osteoarthritis (OA). Inflamed synovium has been associated with both increased symptoms and increased progression in OA patients. Furthermore, synovitis observed during knee arthroscopy in our patients undergoing arthroscopic partial meniscectomy (APM) was associated with worse symptoms while adjusting for confounding factors.Therefore, a better understanding of synovitis as a predictor of outcome after APM and as a target for treatment is needed to improve outcomes in this patient population.
Triamcinolone has been shown to decrease synovitis-associated outcomes in both animal and human studies after anterior cruciate ligament (ACL) injury. In a porcine model of ACL injury, treatment with triamcinolone resulted in decreased formation of synovitis-related collagen breakdown products as well as decreased cellularity of the synovium.And in a trial of triamcinolone injected after ACL injury, similar findings of decreased C-telopeptide of type II collagen (CTX-II), associated with collagen type II breakdown, was found in knees administered triamcinolone compared to placebo controls.
Read the detailed description
Symptomatic meniscal tear with pain and mechanical symptoms of catching and locking ,a phenotype of early OA, and often prompts patients who have failed physical therapy to elect APM to improve their symptoms. This arthroscopic surgery presents a unique opportunity to evaluate the intraarticular status of the joint including joint fluid biomarkers and synovial tissue for signs of inflammation in patients with mild to moderate OA. Since no post-op tissue repair is desired after APM, in contrast to other post-traumatic OA (PTOA) models such as anterior cruciate ligament reconstruction, the APM cohort can be used to test novel interventions to slow down PTOA development by suppressing synovitis and inflammation. Results from this trial in this patient population could be applied to the broader population of many millions of patients with mild to moderate OA who never undergo arthroscopy.
There are currently approximately 1,000,000 APMs performed in the United States each year, and about 70 percent of patients have a clinically significant improvement in symptoms after surgery. Much of this variation in outcome is unexplained but is hypothesized to be related to synovitis and joint inflammation that is currently unmeasured and untreated in usual clinical care.
This is a randomized controlled trial of extended release triamcinolone for efficacy to improve patient reported outcome measures after APM. The investigators will evaluate joint fluid and synovial tissue biomarkers to assess joint inflammation as a predictor of treatment response, use quantitative 3T MRI to evaluate cartilage and meniscus composition and 3D bone shape, which are sensitive imaging markers for early joint degeneration, and use a prospective surgical episode data collection system to capture patient reported outcomes and surgeon reported operative data.
- Conditions
- Osteoarthritis, Knee, Meniscus Tear, Meniscus; Degeneration, Synovitis
- Being tested
- Zilretta Injectable Product or Placebo
- Keywords
- knee pain, arthroscopic partial meniscectomy, post-traumatic OA, patient reported outcome
- Medical subject headings
- Osteoarthritis, Knee, Synovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zilretta Injectable Product or PlaceboDrug
Also called triamcinolone acetonide
The purpose of this intervention is to determine the use of extended release steroid knee injection (Zilretta) at the end of the surgery and its effects on your knee pain.In this study Zilretta will be injected intra-operatively for your arthroscopic partial meniscectomy (APM) surgery.Participants will have MRIs x-rays, and provide a sample of the synovial fluid from both knees at the beginning of surgery. This fluid is drained at the beginning of surgery and then usually discarded. Three samples each of blood and urine will be collected over the study period from each participant and sample of joint (synovial tissue) taken. Participants will be asked to answer questions about knee pain.
| Study group | Role | What they receive |
|---|---|---|
| corticosteroid | Experimental | Triamcinolone extended release (32 mg) administered as an intraarticular injection at the conclusion of arthroscopic partial meniscectomy.
* Knee injury and Osteoarthritis Outcome Score (KOOS) pain at 6 and 12 months
* T1ρ and T2 imaging of cartilage and meniscus at 3 and 12 months
* Morphologic grading of cartilage using the MOAKS score at 3 and 12 months
* 3D bone shape from MRI Osteoarthritis Knee Score (MOAKS) using statistical shape modeling at 3 and 12 months
* Improvement in blood, serum and urine inflammatory biomarker profiles at 3 and 12 months Receives: Drug: Zilretta Injectable Product or Placebo |
| Placebo | Placebo comparator | Normal saline of 5 mL administered as an intraarticular injection at the conclusion of arthroscopic partial meniscectomy.
* KOOS pain at 6 and 12 months
* T1ρ and T2 imaging of cartilage and meniscus at 3 and 12 months
* Morphologic grading of cartilage using the MOAKS score at 3 and 12 months
* 3D bone shape from MRI using statistical shape modeling at 3 and 12 months
* Improvement in blood, serum and urine inflammatory biomarker profiles at 3 and 12 months Receives: Drug: Zilretta Injectable Product or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline and 3 months.
Knee pain of participants; a higher score represents a desired outcome; zero representing extreme knee problems and 100 representing no knee problems
Measured: 0 and 3 months
Secondary outcomes (7)
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline, 6 and 12 months.
Knee pain of participants; a higher score represents a desired outcome; zero representing extreme knee problems and 100 representing no knee problems
Measured: 0, 6, and 12 months
Change in Inflammatory biomarkers in circulation from baseline, 3 and 12 months.
Urine; CTX-II
Measured: 0, 3, and 12 months
Change in Inflammatory biomarkers of the knee joint from baseline, 3, and 12 months.
The increase or decrease from the combination of following markers in the Synovial fluid will help characterize the profile of knee joint; TGF-ß1, neutrophil elastase, IL-1, IL-6, IL-8, TNF, MCP-1, MIP1, MMP-3, MMP-10, MMP activity, sGAG, aggrecanase, TIMP-1, and PGE2
Measured: 0, 3, and 12 months
Change in Inflammatory biomarkers in circulation from baseline, 3 and 12 months.
The increase or decrease from the combination of the following markers in the serum will help characterize the inflammatory profile of the individual systemically; hyaluronic acid, IL-1, IL-6, IL-8, TNF, TIMP-1, MMP-10, MCP-1, MIP1, and PGE2
Measured: 0, 3 and 12 months
Change in Magnetic Resonance Imaging relaxation time (milliseconds of T1 and T2) from baseline, 3, and 12 months.
Quantitative measurement of cartilage, longer relaxation time represents a poor outcome
Measured: 0, 3 and 12 months
Change in Whole-Organ Magnetic Resonance Imaging Score (WORMS) from baseline, 3, and 12 months.
Bone shape, a higher score represents a poor outcome; zero representing no knee problems and 332 representing knee problems
Measured: 0, 3 and 12 months
Change in Magnetic Resonance Imaging morphological grading from baseline, 3, and 12 months.
Modified MRI Osteoarthritis Knee Score (MOAKS); a higher score represents a poor outcome; zero representing no knee problems and 332 representing knee problems
Measured: 0, 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start27 May 2021
- Primary completion1 Aug 2026
- Study completion1 Aug 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 The Cleveland ClinicThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Foundation
- Responsible party
- Principal investigator, Kurt Spindler, MD, Arthritis Foundation
- Investigators
- Morgan Jones, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641351
- Sponsor's protocol ID
- 20-1074
- Acronym
- CoMeT
- Status last verified
- Mar 2026
- First submitted
- 15 Oct 2020
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection After Arthroscopic Partial Meniscectomy
- ClinicalTrials.gov ID
- NCT04641351
- Acronym / sponsor ID
- CoMeT / 20-1074
- Conditions
- Osteoarthritis, Knee, Meniscus Tear, Meniscus; Degeneration, Synovitis
- Keywords
- knee pain, arthroscopic partial meniscectomy, post-traumatic OA, patient reported outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Arthritis Foundation
- Study start
- 27 May 2021 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 23 Nov 2020 (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.
Synovitis has an important role in the symptoms and progression of Osteoarthritis (OA). Inflamed synovium has been associated with both increased symptoms and increased progression in OA patients. Furthermore, synovitis observed during knee arthroscopy in our patients undergoing arthroscopic partial meniscectomy (APM) was associated with worse symptoms while adjusting for confounding factors.Therefore, a better understanding of synovitis as a predictor of outcome after APM and as a target for treatment is needed to improve outcomes in this patient population.
Triamcinolone has been shown to decrease synovitis-associated outcomes in both animal and human studies after anterior cruciate ligament (ACL) injury. In a porcine model of ACL injury, treatment with triamcinolone resulted in decreased formation of synovitis-related collagen breakdown products as well as decreased cellularity of the synovium.And in a trial of triamcinolone injected after ACL injury, similar findings of decreased C-telopeptide of type II collagen (CTX-II), associated with collagen type II breakdown, was found in knees administered triamcinolone compared to placebo controls.
Detailed description
Symptomatic meniscal tear with pain and mechanical symptoms of catching and locking ,a phenotype of early OA, and often prompts patients who have failed physical therapy to elect APM to improve their symptoms. This arthroscopic surgery presents a unique opportunity to evaluate the intraarticular status of the joint including joint fluid biomarkers and synovial tissue for signs of inflammation in patients with mild to moderate OA. Since no post-op tissue repair is desired after APM, in contrast to other post-traumatic OA (PTOA) models such as anterior cruciate ligament reconstruction, the APM cohort can be used to test novel interventions to slow down PTOA development by suppressing synovitis and inflammation. Results from this trial in this patient population could be applied to the broader population of many millions of patients with mild to moderate OA who never undergo arthroscopy.
There are currently approximately 1,000,000 APMs performed in the United States each year, and about 70 percent of patients have a clinically significant improvement in symptoms after surgery. Much of this variation in outcome is unexplained but is hypothesized to be related to synovitis and joint inflammation that is currently unmeasured and untreated in usual clinical care.
This is a randomized controlled trial of extended release triamcinolone for efficacy to improve patient reported outcome measures after APM. The investigators will evaluate joint fluid and synovial tissue biomarkers to assess joint inflammation as a predictor of treatment response, use quantitative 3T MRI to evaluate cartilage and meniscus composition and 3D bone shape, which are sensitive imaging markers for early joint degeneration, and use a prospective surgical episode data collection system to capture patient reported outcomes and surgeon reported operative data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| corticosteroid | Experimental | Drug: Zilretta Injectable Product or PlaceboTriamcinolone extended release (32 mg) administered as an intraarticular injection at the conclusion of arthroscopic partial meniscectomy. * Knee injury and Osteoarthritis Outcome Score (KOOS) pain at 6 and 12 months * T1ρ and T2 imaging of cartilage and meniscus at 3 and 12 months * Morphologic grading of cartilage using the MOAKS score at 3 and 12 months * 3D bone shape from MRI Osteoarthritis Knee Score (MOAKS) using statistical shape modeling at 3 and 12 months * Improvement in blood, serum and urine inflammatory biomarker profiles at 3 and 12 months |
| Placebo | Placebo comparator | Drug: Zilretta Injectable Product or PlaceboNormal saline of 5 mL administered as an intraarticular injection at the conclusion of arthroscopic partial meniscectomy. * KOOS pain at 6 and 12 months * T1ρ and T2 imaging of cartilage and meniscus at 3 and 12 months * Morphologic grading of cartilage using the MOAKS score at 3 and 12 months * 3D bone shape from MRI using statistical shape modeling at 3 and 12 months * Improvement in blood, serum and urine inflammatory biomarker profiles at 3 and 12 months |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female age 40 and older
- Scheduled for APM with enrolling surgeon
- Arthroscopic evidence of structural OA including at least one surface with grade 2 chondral change
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Key exclusion criteria (11 listed)
- Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to inseminate a partner or donate sperm
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Known or suspected hypersensitivity to Zilretta (or component of Zilretta) or triamcinolone acetonide
- Kellgren and Lawrence Grade IV (severe OA; arthroplasty is typically preferred over APM in this setting)
- Injection with corticosteroid into affected knee in past 12 weeks
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 |
|---|---|---|
| Zilretta Injectable Product or PlaceboAlso: triamcinolone acetonideThe purpose of this intervention is to determine the use of extended release steroid knee injection (Zilretta) at the end of the surgery and its effects on your knee pain.In this study Zilretta will be injected intra-operatively for your arthroscopic partial meniscectomy (APM) surgery.Participants will have MRIs x-rays, and provide a sample of the synovial fluid from both knees at the beginning of surgery. This fluid is drained at the beginning of surgery and then usually discarded. Three samples each of blood and urine will be collected over the study period from each participant and sample of joint (synovial tissue) taken. Participants will be asked to answer questions about knee pain. | Drug | Placebo, corticosteroid |
Primary outcome
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline and 3 months.
Time frame: 0 and 3 months
Knee pain of participants; a higher score represents a desired outcome; zero representing extreme knee problems and 100 representing no knee problems
7 secondary outcomes
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline, 6 and 12 months.
Time frame: 0, 6, and 12 months
Change in Inflammatory biomarkers in circulation from baseline, 3 and 12 months.
Time frame: 0, 3, and 12 months
Change in Inflammatory biomarkers of the knee joint from baseline, 3, and 12 months.
Time frame: 0, 3, and 12 months
Change in Inflammatory biomarkers in circulation from baseline, 3 and 12 months.
Time frame: 0, 3 and 12 months
Change in Magnetic Resonance Imaging relaxation time (milliseconds of T1 and T2) from baseline, 3, and 12 months.
Time frame: 0, 3 and 12 months
Change in Whole-Organ Magnetic Resonance Imaging Score (WORMS) from baseline, 3, and 12 months.
Time frame: 0, 3 and 12 months
Change in Magnetic Resonance Imaging morphological grading from baseline, 3, and 12 months.
Time frame: 0, 3 and 12 months
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 31 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Morgan Jones, MD, MPH principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Osteoarthritis, Knee and Meniscus Tear, run by The Cleveland Clinic at 2 sites in United States.
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 11 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: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline and 3 months. (time frame: 0 and 3 months). 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 31 Aug 2026.