Early Treatment for Acute ACL Tear

Plain-language summary

This study looks at a drug called Kenalog, compared with placebo, as an early treatment for people with an acute anterior cruciate ligament (ACL) tear that happened during sport. It enrolled physically active people who injured their ACL while playing a sport and had a healthy opposite knee. The study was carried out in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Cale Jacobs

Intervention

Kenalog or placebo, Kenalog then Placebo, Kenalog, Placebo

Start date

3/1/2013

Estimated completion

2/5/2017

Countries

United States

Related genes

Locations

• Lexington, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* currently participating in sporting activities
* Normal contralateral knee status
* Anterior Cruciate Ligament (ACL) injury occurred while playing a sporting activity

Exclusion Criteria:

* underlying inflammatory disease (i.e. Rheumatoid Arthritis, Psoriatic Arthritis, etc.)
* have been diagnosed with hepatitis B or tuberculosis
* currently have an infection, including infection of the skin
* have a disease that weakens your immune system such as diabetes, cancer, HIV or AIDs
* other major medical condition requiring treatment with immunosuppressant or modulating drugs.
* A history of chronic use of non-steroidal anti-inflammatory drugs
* previous exposure or allergic reaction to Kenalog
* prior knee surgery (Ipsilateral or contralateral)
* have received any investigational drug with 4 weeks of study Visit 1