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

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Austin V Stone
• Treatments: Anti-Inflammatory Agents; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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 undergone arthroscopic ACL reconstruction with partial meniscectomy or meniscal repair in the past 4 weeks

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-6 concentration > 317 pg/mL four weeks following 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