Early Treatment for Acute ACL Tear

Condition(s) targeted: Anterior Cruciate Ligament (ACL) Tears

Intervention: Kenalog or placebo (Drug); Kenalog then Placebo (Drug); Kenalog (Drug); Placebo (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Christian Lattermann

Official(s) and/or principal investigator(s):
Christian Lattermann, MD, Principal Investigator, Affiliation: University of Kentucky, Department of Orthopaedic Surgery

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.

Official title: Early Anti-inflammatory Treatment in Patients With Acute ACL Tear

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Efficacy of Kenalog to alleviate knee pain

Secondary outcome: Kenalog therapy improves levels of a panel of inflammatory (cytokine), meniscus and cartilage metabolism and oxidative stress biomarkers

Detailed 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.

Minimum age: 14 Years. Maximum age: 33 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- currently participating in sporting activities

- Normal contralateral knee status

- 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

UK HeathCare Sports Medicine, Lexington, Kentucky 40517, United States

Starting date: March 2013
Last updated: December 10, 2014