Status:
TERMINATED
Success of Long-acting Anti-inflammatories After Anterior Cruciate Ligament and Meniscal Injury
Lead Sponsor:
Austin V Stone
Conditions:
Tibial Meniscus Injuries
Tibial Meniscus Tears
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief 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 (A...
Detailed Description
Anterior cruciate ligament (ACL) injury initiates a biochemical cascade that leads to cartilage degradation and the development of posttraumatic osteoarthritis (PTOA). ACL and acute traumatic meniscus...
Eligibility Criteria
Inclusion
- 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
- 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
- History of infection in either knee joint
- 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
- Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
- Females who are pregnant or nursing or plan to become pregnant during the study; men whose female partner plans to conceive during the study
- Radiographic osteoarthritic changes defined as Kellgren-Lawrence grade 2 or greater (as determined by PI from patient's preoperative X-rays)
- Inability to read and understand English
Key Trial Info
Start Date :
August 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04331002
Start Date
August 21 2020
End Date
July 11 2022
Last Update
July 27 2023
Active Locations (1)
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1
UK Healthcare at Turfland
Lexington, Kentucky, United States, 40504