Success of Long-acting Anti-inflammatories After Anterior Cruciate Ligament and Meniscal Injury

53136

The purpose of this study is to determine if extended-release triamcinolone acetonide treatment alters the progressive changes in bone shape previously demonstrated after anterior cruciate ligament (ACL) reconstruction with partial meniscectomy or meniscal repair.

2020-08-21

2022-07-11

2022-07-11

Terminated

Early phase I

1

Inclusion Criteria: 1. Written consent to participate in the study 2. Male or female greater than or equal to 18 years of age and less than 40 years of age 3. Has been consented to undergo arthroscopic ACL reconstruction with partial meniscectomy or meniscal repair 4. Ambulatory and in good general health 5. Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions. 6. Willing to abstain from use of protocol-restricted medications during the study 7. Females and males who have reproductive potential: Must use highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation (10 weeks; 4 to 14 weeks after surgery) 8. Demonstrate persistent inflammation defined as synovial fluid IL-1a concentration greater than or equal to 5 pg/mL at the time of surgery Exclusion Criteria: 1. Known allergic reactions to components of the extended-release triamcinolone acetonide (Zilretta®) 2. Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease 3. History of infection in either knee joint 4. Clinical signs and symptoms of active knee infection or crystal disease in either knee within 1 month of Screening 5. Other surgery or arthroscopy of either knee within 6 months of Screening 6. Intraarticular treatment of any joint with any of the following agents within six (6) months of Screening: any corticosteroid preparation or any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed). 7. Intraarticular treatment in either knee with hyaluronic acid (investigational or marketed) within 6 months of Screening 8. Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening 9. Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening 10. Females who are pregnant or nursing or plan to become pregnant during the study; men whose female partner plans to conceive during the study 11. Radiographic osteoarthritic changes defined as Kellgren-Lawrence grade 2 or greater (as determined by PI from patient's preoperative X-rays) 12. Inability to read and understand English

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'After providing informed consent prior to ACL reconstruction with meniscal involvement, synovial fluid will be collected and assessed for the concentration of pro-inflammatory cytokine interleukin-1alpha (IL-1a). This will be done to identify patients that present with persistent inflammation after surgery that may be at increased risk of cartilage degradation.\n\nPatients with elevated IL-1a, defined as concentrations \\> 5 pg/mL, will then be randomized to one of two groups. The threshold of 5 pg/mL was based on our pilot study of 19 patients.\n\nFor those with elevated IL-1a, eight weeks after surgery the knee will be aspirated and one group will receive a single 32 mg Zilretta injection and the other group will receive a 5 mL saline injection.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'The knee will be aspirated and one group will receive a single 32 mg Zilretta injection and the other group will receive a 5 mL saline injection. The syringes will be blinded to ensure that both the investigator administering the injection and the patient will be blinded to the group assignment.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1, 'type': 'ACTUAL'}}

2023-07-27