Corticosteroid Meniscectomy Randomized Trial

NCT04641351 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 20-1074
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Osteoarthritis, Knee; Meniscus Tear; Meniscus; Degeneration; Synovitis

Keywords

knee pain; arthroscopic partial meniscectomy; post-traumatic OA; patient reported outcome

Outcome Measures

Primary Outcomes (1)

• 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

  0 and 3 months

Secondary Outcomes (7)

• Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline, 6 and 12 months.

  0, 6, and 12 months

• Change in Inflammatory biomarkers in circulation from baseline, 3 and 12 months.

  0, 3, and 12 months

• Change in Inflammatory biomarkers of the knee joint from baseline, 3, and 12 months.

  0, 3, and 12 months

• Change in Inflammatory biomarkers in circulation from baseline, 3 and 12 months.

  0, 3 and 12 months

• Change in Magnetic Resonance Imaging relaxation time (milliseconds of T1 and T2) from baseline, 3, and 12 months.

  0, 3 and 12 months

Study Arms (2)

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

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

Drug: Zilretta Injectable Product or Placebo

Interventions

Zilretta Injectable Product or Placebo DRUG

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.

Also known as: triamcinolone acetonide

Placebo; corticosteroid

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Arthritis Foundation: collaborator

Study Sites (2)

Bringham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Synovitis

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Morgan Jones, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Grant PI

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: November 23, 2020
• Study Start: May 27, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)