Early Treatment for Acute ACL Tear (AAA)

Cale Jacobs

Status and phase: Completed; Phase 2

Conditions: Anterior Cruciate Ligament (ACL) Tears

Treatments: Drug: Placebo; Drug: Kenalog or placebo; Drug: Kenalog; Drug: Kenalog then Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01692756

12-0706

Details and patient eligibility

About

This research study is the first of its kind and will allow health care professionals and researchers to answer many questions about the reasons why anterior cruciate ligament (ACL) injury leads to knee pain and disability and osteoarthritis. We also hope that this study will be the beginning of new, more powerful and safer drugs to help patients with ACL injuries heal sooner and return to sports or daily activities pain free. Study participants will be recruited from the University of Kentucky and Vanderbilt University.

The purpose of this research is to gather information on how safe and effective Kenalog® is in alleviating knee pain following ACL rupture.

Full description

Injury to the knee during sports participation often involves partial of full detachment of the ACL. ACL tears cause pain, swelling and inflammation. While the swelling and inflammation usually goes away in time, individuals with ACL injuries may experience pain and notice knee instability (knee slipping, etc.). Often surgery can repair or replace the ACL within the joint, allowing individuals the ability to walk or run again pain free or participate in sports. Unfortunately, osteoarthritis of the knee, which also causes pain and swelling, can occur in that same knee 10-20 years later for reasons which are not well understood.

In this research study, we hope to prevent and reduce the initial post-operative pain. The reduction of pain will allow for earlier movement of the knee joint and preparation for surgery. It may also reduce the risk to develop osteoarthritis in individuals with ACL injuries by treating them within 1-2 days after their injury.

Enrollment: 49 patients

Sex: All

Ages: 14 to 33 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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49 participants in 4 patient groups, including a placebo group

Kenalog or Placebo

Experimental group

Description:

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Treatment:

Drug: Kenalog or placebo

Kenalog then placebo

Experimental group

Description:

Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.

Treatment:

Drug: Kenalog then Placebo

Kenalog only

Experimental group

Description:

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Treatment:

Drug: Kenalog

Placebo

Placebo Comparator group

Description:

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Treatment:

Drug: Placebo