Corticosteroid Meniscectomy Randomized Trial (CoMeT)
Osteoarthritis, Knee, Meniscus Tear, Meniscus; Degeneration
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring knee pain, arthroscopic partial meniscectomy, post-traumatic OA, patient reported outcome
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Sites / Locations
- Cleveland Clinic Foundation
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
corticosteroid
Placebo
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
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