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NCT03968913 · ClinicalTrials.gov registry record · Early Phase 1

Biologic Therapy to Prevent Osteoarthritis After ACL Injury

A Early Phase 1 study of Anterior Cruciate Ligament Injuries, sponsored by University of California, Los Angeles.

Recruiting
Registry status
Early Phase 1
Development phase
32
Enrollment target
1
Study location

NCT03968913 is a Early Phase 1 study of Anterior Cruciate Ligament Injuries that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 32 participants, below the 322-participant average among 24 other Anterior Cruciate Ligament Injuries trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03968913, a Early Phase 1 study of Anterior Cruciate Ligament Injuries, is actively recruiting participants, sponsored by University of California, Los Angeles.

RECRUITING
Registry status
Early Phase 1
Development phase
32 participants
Enrollment target
1
Study location

Study Summary

Anterior cruciate ligament (ACL) injuries are extremely common. On average, 50% of individuals suffering an ACL injury will develop radiographic osteoarthritis (OA) 10 to 20 years after injury. Unfortunately, ACL reconstruction does not prevent risk of future OA. Interleukin-1 (IL-1) levels in the human knee joint increase transiently after an ACL injury. In animal experiments, if interleukin-1 levels are increased in the joint, this alone causes arthritis to occur. Interleukin-1 receptor antagonist (IL-1Ra) is a naturally occurring inhibitor of IL-1. However, in ACL injuries the balance of these two proteins is disturbed transiently after injury, with the effects of IL-1 dominating this balance. In a large animal model of ACL injury, injection of IL-1Ra into the knee joint after ACL injury significantly decreased the amount of arthritis that was later observed. Thus, the investigators hypothesize that early injection of IL-1 inhibitor (IL-1Ra) into the knee joint of patients suffering recent ACL injury will decrease the incidence of cartilage damage later in life. After appropriate IRB approval, a total of 32 active patients will be randomized into one of two treatment groups. Group 1 will receive removal of the knee joint fluid (aspiration of hemarthrosis) using a needle and syringe within 1 to 2 weeks of injury. Following aspiration of the knee joint, an injection of 5 milliliters (mls) of sterile saline (as a placebo control) will be administered. In addition, a second knee aspiration procedure and an injection of 5mls of sterile saline into the injured knee joint will be performed at 3 to 5 days after the initial injection. Group 2 will receive aspiration of the knee hemarthrosis as described in group 1 as well as intra-articular administration of 150mg (\~5mls) of anakinra (rhIL-1Ra) within 1 to 2 weeks of ACL injury. In addition, a second knee aspiration and intra-articular administration of 150mg (\~5mls) of anakinra (rhIL-1Ra) will be performed at 3 to 5

Conditions Studied

Anterior Cruciate Ligament Injuries

Interventions

  • DRUG Anakinra injection
  • PROCEDURE sterile saline injection

Study Locations (1)

California

  • University of California, Los Angeles - Los Angeles

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2021-09-15
Est. Completion 2027-01-30
Phase Early Phase 1

Sponsor

University of California, Los Angeles

897 total trials

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What the Registry Record Tells You About NCT03968913

The ClinicalTrials.gov registry entry for NCT03968913 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 322-participant average among 24 other Anterior Cruciate Ligament Injuries trials with a reported enrollment target (90% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Anterior Cruciate Ligament Injuries appearing as the primary indexed condition, and to 2 interventions - of which Anakinra injection is the first listed.

NCT03968913 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT03968913 about?

NCT03968913 is a clinical study titled "Biologic Therapy to Prevent Osteoarthritis After ACL Injury". Anterior cruciate ligament (ACL) injuries are extremely common. On average, 50% of individuals suffering an ACL injury will develop radiographic osteoarthritis (OA) 10 to 20 years after injury. Unfortunately, ACL reconstruction does not prevent risk of future OA. Interleukin-1 (IL-1) levels in the ...

What is the current status of trial NCT03968913?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 32 participants. The study started on 2021-09-15. Estimated completion is 2027-01-30.

What conditions does trial NCT03968913 study?

This clinical trial studies the following conditions: Anterior Cruciate Ligament Injuries.

What interventions are being tested in trial NCT03968913?

The interventions under investigation include: Anakinra injection (DRUG), sterile saline injection (PROCEDURE).

Who is sponsoring clinical trial NCT03968913?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03968913 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.