Effects of intraarticular IL1-Ra for acute anterior cruciate ligament knee injury: a randomized controlled pilot trial (NCT00332254).
V B Kraus, J Birmingham, T V Stabler...
https://pubmed.ncbi.nlm.nih.gov/22273632Actively Recruiting
Early Phase 1
Age: 18Years - 35Years
All Genders
Healthy Volunteers
ID03968913
Biologic Therapy to Prevent Osteoarthritis After ACL Injury
Led by University of California, Los Angeles · Updated on 2026-01-26
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
O
Orthopedic Research and Education Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of biologic therapy to prevent osteoarthritis in active patients who have suffered an anterior cruciate ligament (ACL) injury. This trial evaluates whether early injections of an interleukin-1 inhibitor, called anakinra, can reduce cartilage damage later in life compared to placebo injections. The study is designed as a randomized, placebo-controlled trial with 32 participants aged 18 to 35 years. Participants will be randomly assigned to one of two groups. Group 1 will receive two injections of sterile saline into the injured knee joint within 1 to 2 weeks of injury and again 3 to 5 days later. Group 2 will receive two injections of anakinra combined with sterile saline at the same time points. Both groups will undergo knee fluid removal (arthrocentesis) during these procedures and prior to surgery. Ultrasound guidance will be used when feasible to assist with injections. Throughout the study, participants will provide urine and knee joint fluid samples at multiple times before and after surgery for biomarker analysis. They will also complete surveys about knee pain and function before surgery and up to 24 months after. MRI scans, including special cartilage-sensitive sequences, will be performed at 1 and 2 years post-surgery to assess cartilage health. The primary outcomes include measuring cytokine levels and cartilage biomarkers in synovial fluid. The study is double-blinded to patients and outcome assessors to minimize bias.
CONDITIONS
Brief Title
Biologic Therapy to Prevent Osteoarthritis After ACL Injury
Who Can Participate
Age: 18Years - 35Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 35 years with closed growth plates seen on X-rays who participate in cutting and pivoting activities
- Equal number of men and women in each treatment group (8 men and 8 women per group)
- MRI-confirmed ACL injury within 2 weeks of presentation
- Plan to undergo bone-patellar tendon-bone ACL reconstruction surgery within 45 days of injury
- No clinical or MRI evidence of posterior cruciate ligament injury
- No more than grade 1 medial collateral ligament injury
- No concurrent posterolateral corner injury to the same knee
You will not qualify if you...
- Injury occurred more than 2 weeks before enrollment
- Previous injury to the same knee
- Multi-ligament knee injury
- Existing or concurrent grade 3 or 4 cartilage injuries
- Previous surgery on the same knee (meniscus tear, ACL tear, cartilage injury, etc.)
- Active infection
- Known allergy or adverse reaction to anakinra
- Cortisone injection in either knee within 3 months before injury
- Prior exposure to interleukin-1 receptor antagonist
- Participation in another clinical drug trial within 4 weeks before injury
- History of blood clotting disorders or current use of blood thinners
- Current cancer
- Current inflammatory or rheumatologic disease
- Current immune system compromise
- Current kidney failure
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - Up to 2 weeks from injury
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 45 days from injury until surgery
Participants receive two knee joint injections and arthrocentesis procedures prior to ACL reconstruction surgery. Group 1 receives sterile saline injections, and Group 2 receives anakinra injections. Arthrocentesis is performed at enrollment, 3 to 5 days after initial injection, and at the time of surgery.
3 visits (in-person) before surgery
Post-operative Follow-up
Duration - 24 months post-surgery
Participants undergo urine and knee fluid sample collection and complete patient-reported outcome assessments after surgery. Urine samples are collected at approximately 8-10 days post-surgery and then at 3, 6, 9, 12, and 24 months post-operatively. Patient surveys occur at 6, 9, 12, and 24 months post-surgery. MRI assessments are performed at 1 and 2 years post-operatively.
Approximately 7 visits (in-person) over 2 years
Trial Site Locations
Total: 1 location
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
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Research Team
A
Adreanne Rivera
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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