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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.

Compiled by PlainTrial · August 8, 2026

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

NCT03968913: Recruiting Early Phase 1 study of Anterior Cruciate Ligament Injuries, sponsored by University of California, Los Angeles.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Synovial fluid samples will be analyzed for a change in the level of interleukin-1 and interleukin-1 receptor antagonist levels using enzyme-linked immunosorbent assays (ELISA).

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

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

University of California, Los Angeles

897 total trials

What NCT03968913 shows while recruiting

NCT03968913 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 322-participant average among 24 other Anterior Cruciate Ligament Injuries trials with a reported enrollment target (90% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Anterior Cruciate Ligament Injuries

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03968913's enrollment target sits among peer trials

32 23rd of 24 higher than 2 of 24 other Anterior Cruciate Ligament Injuries trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Anterior Cruciate Ligament Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03968913, the US trial registry maintained by the National Library of Medicine. NCT03968913 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.