Overview

This trial is active, not recruiting.

Condition anterior cruciate ligament (acl) tears
Treatments kenalog or placebo, kenalog then placebo, kenalog, placebo
Phase phase 2
Sponsor Christian Lattermann
Collaborator Vanderbilt University
Start date March 2013
End date September 2017
Trial size 68 participants
Trial identifier NCT01692756, 12-0706

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.
kenalog or placebo Drug: Kenalog
(Experimental)
Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.
kenalog then placebo Drug: Kenalog
(Experimental)
Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®
kenalog Drug: Kenalog
(Placebo Comparator)
subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.
placebo Drug Placebo (for Kenalog)

Primary Outcomes

Measure
Efficacy of Kenalog to alleviate knee pain
time frame: Patients will be evaluated for changes in pain at 5 post-injury time points (1-2 days), 12-14 days, 2 weeks post-op, 4 weeks post-op and 6 months post-op)

Secondary Outcomes

Measure
Kenalog therapy improves levels of a panel of inflammatory (cytokine), meniscus and cartilage metabolism and oxidative stress biomarkers
time frame: 1-7 days, 10-17 days after injury and at time of surgery

Eligibility Criteria

Male or female participants from 14 years up to 33 years old.

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

Additional Information

Official title Early Anti-inflammatory Treatment in Patients With Acute ACL Tear
Principal investigator Christian Lattermann, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Kentucky.