Early Treatment for Acute ACL Tear (AAA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01692756
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : February 8, 2017
Vanderbilt University
Information provided by (Responsible Party):
Christian Lattermann, University of Kentucky

Brief 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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament (ACL) Tears Drug: Kenalog or placebo Drug: Kenalog then Placebo Drug: Kenalog Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Early Anti-inflammatory Treatment in Patients With Acute ACL Tear
Study Start Date : March 2013
Actual Primary Completion Date : February 5, 2017
Actual Study Completion Date : February 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Kenalog or Placebo
Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.
Drug: Kenalog or placebo
Other Names:
  • Drug: Kenalog
  • Other Names:
  • triamcinolone acetonide injectable suspension
  • Drug Placebo (for Kenalog)
  • physiologic Saline solution

Experimental: Kenalog then placebo
Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.
Drug: Kenalog then Placebo
Other Names:
  • Drug: Kenalog
  • Other Names:
  • triamcinolone acetonide injectable suspension
  • Drug Placebo (for Kenalog)
  • physiologic saline solution

Experimental: Kenalog only
Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®
Drug: Kenalog
Other Names:
  • Drug: Kenalog
  • Other Names:
  • triamcinolone acetonide injectable suspension

Placebo Comparator: Placebo
subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.
Drug: Placebo
Other Names:
  • Drug Placebo (for Kenalog)
  • physiologic saline solution

Primary Outcome Measures :
  1. 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) ]
    This trial will use the standardized patient self-report Knee Injury and Osteoarthritis Outcome Score (KOOS) instrument to assess pain and function in response to the intervention for acute ACL injury. This trial will supplement the KOOS with function score assessments from the International Knee Documentation Committee (IKDC) form for evaluation of knee ligament injuries

Secondary Outcome Measures :
  1. 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 ]
    Biomarkers to be tested include IL-1α, IL-1β, Collagen type I (NtxI) and collagen type II (CTXII) breakdown products, cartilage oligomeric protein (COMP) and glycomsaminoglycan (GAG) and Xanthine Oxidase. Additionally, the change in IL-1α/β levels in the IL-1Ra treated and placebo individuals will be evaluated specifically for association with pain and function outcomes.

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 33 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01692756

United States, Kentucky
UK HeathCare Sports Medicine
Lexington, Kentucky, United States, 40517
Sponsors and Collaborators
Christian Lattermann
Vanderbilt University
Principal Investigator: Christian Lattermann, MD University of Kentucky, Department of Orthopaedic Surgery

Publications of Results:
Responsible Party: Christian Lattermann, Sponsor/Investigator, University of Kentucky Identifier: NCT01692756     History of Changes
Other Study ID Numbers: 12-0706
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Pharmaceutical Solutions
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action