Success of Long-acting Anti-inflammatories After Anterior Cruciate Ligament and Meniscal Injury (NCT04331002) | Clinical Trial Compass
TerminatedPhase 2
Success of Long-acting Anti-inflammatories After Anterior Cruciate Ligament and Meniscal Injury
Stopped: Funding Termination
United States1 participantsStarted 2020-08-21
Plain-language summary
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.
Who can participate
Age range18 Years – 40 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Written consent to participate in the study
✓. Male or female greater than or equal to 18 years of age and less than 40 years of age
✓. Has been consented to undergo arthroscopic ACL reconstruction with partial meniscectomy or meniscal repair
✓. Ambulatory and in good general health
✓. Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions.
✓. Willing to abstain from use of protocol-restricted medications during the study
✓. 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)
✓. 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
✕. Known allergic reactions to components of the extended-release triamcinolone acetonide (Zilretta®)
✕. Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
. Clinical signs and symptoms of active knee infection or crystal disease in either knee within 1 month of Screening
✕. Other surgery or arthroscopy of either knee within 6 months of Screening
✕. 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).
✕. Intraarticular treatment in either knee with hyaluronic acid (investigational or marketed) within 6 months of Screening
✕. Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening