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Early Treatment for Acute ACL Tear (AAA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Kentucky
Sponsor:
Information provided by (Responsible Party):
Christian Lattermann, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01692756
First received: September 11, 2012
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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.

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Early Anti-inflammatory Treatment in Patients With Acute ACL Tear

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 68
Study Start Date: March 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   14 Years to 33 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692756

Contacts
Contact: Christian Lattermann, MD (859) 218-3064 christian.lattermann@uky.edu
Contact: Laura Ashe (859) 323-2782 laura.ashe@uky.edu

Locations
United States, Kentucky
UK HeathCare Sports Medicine Recruiting
Lexington, Kentucky, United States, 40517
Contact: Mary Proffitt    859-218-0519    mkprof0@uky.edu   
Contact: Christian Lattermann, MD    (859) 218-3065    Christian.Lattermann@uky.edu   
Principal Investigator: Christian Lattermann, MD         
Sponsors and Collaborators
Christian Lattermann
Investigators
Principal Investigator: Christian Lattermann, MD University of Kentucky, Department of Orthopaedic Surgery
  More Information

No publications provided

Responsible Party: Christian Lattermann, Sponsor/Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT01692756     History of Changes
Other Study ID Numbers: 12-0706
Study First Received: September 11, 2012
Last Updated: February 21, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014