Anterior Cruciate Ligament Tear Clinical Trial
— SLAMOfficial title:
Success of Long-acting Anti-inflammatories After Anterior Cruciate Ligament and Meniscal Injury
Verified date | July 2023 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | July 11, 2022 |
Est. primary completion date | July 11, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UK Healthcare at Turfland | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Austin V Stone |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Bone Shape (Baseline to 4 Months) | Using manual segmentation, the volume of the medial femoral condyle will be quantified from 3-Tesla magnetic resonance imaging (MRI) scans performed before and 4 months after the study injection. Medial condyle volume will be expressed as cm3. | Baseline, 4 months | |
Secondary | Change in IKDC (Baseline to 4 Months) | The International Knee Documentation Committee (IKDC) scores range from 0-100 with greater scores being indicative of greater self-reported function and reduced pain. | Baseline, 4 months, 1 year, 2 years | |
Secondary | Change in IKDC (Baseline to 1 Year) | The International Knee Documentation Committee (IKDC) scores range from 0-100 with greater scores being indicative of greater self-reported function and reduced pain. | Baseline, 4 months, 1 year, 2 years | |
Secondary | Change in IKDC (Baseline to 2 Years) | The International Knee Documentation Committee (IKDC) scores range from 0-100 with greater scores being indicative of greater self-reported function and reduced pain. | Baseline, 4 months, 1 year, 2 years | |
Secondary | Change in KOOS Global (Baseline to 4 Months) | The Knee injury and Osteoarthritis Outcome Score (KOOS) Global scores range from 0-100 with greater scores being indicative of greater self-reported knee function and reduced pain and symptoms. | Baseline, 4 months, 1 year, 2 years | |
Secondary | Change in KOOSglobal (Baseline to 1 Year) | The Knee injury and Osteoarthritis Outcome Score (KOOS) Global scores range from 0-100 with greater scores being indicative of greater self-reported knee function and reduced pain and symptoms. | Baseline, 4 months, 1 year, 2 years | |
Secondary | Change in KOOSglobal (Baseline to 2 Years) | The Knee injury and Osteoarthritis Outcome Score (KOOS) Global scores range from 0-100 with greater scores being indicative of greater self-reported knee function and reduced pain and symptoms. | Baseline, 4 months, 1 year, 2 years | |
Secondary | Change in ICOAP (Baseline to 4 Months) | The Intermittent and Constant Osteoarthritis Pain (ICOAP) Score is a valid and reliable tool to assess osteoarthritis-related pain. Scores range from 0 to 100, with greater scores indicating worse pain. | Baseline, 4 months, 1 year, 2 years | |
Secondary | Change in ICOAP (Baseline to 1 Year) | The Intermittent and Constant Osteoarthritis Pain (ICOAP) Score is a valid and reliable tool to assess osteoarthritis-related pain. Scores range from 0 to 100, with greater scores indicating worse pain. | Baseline, 4 months, 1 year, 2 years | |
Secondary | Change in ICOAP (Baseline to 2 Years) | The Intermittent and Constant Osteoarthritis Pain (ICOAP) Score is a valid and reliable tool to assess osteoarthritis-related pain. Scores range from 0 to 100, with greater scores indicating worse pain. | Baseline, 4 months, 1 year, 2 years | |
Secondary | Change in CTXII (Baseline to 4 Months) | C-terminal cross-linked telopeptides (CTX); CTXII levels measured by ELISA. CTXII is a biomarker of type II collagen breakdown | Baseline, 4 months |
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