Clinical trial

Injection After Arthroscopic Partial Meniscectomy

Name
20-1074
Description
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.
Trial arms
Trial start
2021-05-27
Estimated PCD
2025-03-22
Trial end
2025-05-01
Phase
Early phase I
Treatment
Zilretta Injectable Product or Placebo
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.
Arms:
Placebo, corticosteroid
Other names:
triamcinolone acetonide
Size
150
Primary endpoint
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline and 3 months.
0 and 3 months
Eligibility criteria
Inclusion Criteria: 1. Male or female age 40 and older 2. Scheduled for APM with enrolling surgeon 3. Arthroscopic evidence of structural OA including at least one surface with grade 2 chondral change 4. 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: 1. Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to inseminate a partner or donate sperm 2. 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. 3. Known or suspected hypersensitivity to Zilretta (or component of Zilretta) or triamcinolone acetonide 4. Kellgren and Lawrence Grade IV (severe OA; arthroplasty is typically preferred over APM in this setting) 5. Injection with corticosteroid into affected knee in past 12 weeks 6. Injection with platelet rich plasma into affected knee in past 12 weeks 7. Injection with hyaluronic acid into affected knee in past 24 weeks 8. Plan for cartilage resurfacing procedure (microfracture, autologous chondrocyte implantation, osteochondral autograft or allograft), ligament reconstruction or other open procedure 9. Bilateral surgery 10. Unable to undergo MRI due to implanted medical device, aneurysm clamp, metal fragments in eye, etc. 11. Absence of at least one area of grade 2 chondral change on diagnostic arthroscopy (patients without structural OA are excluded)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2024-04-05

1 organization

1 product

5 indications

Product
Zilretta
Indication
Osteoarthritis
Indication
Knee
Indication
Meniscus Tear
Indication
Synovitis