Early Treatment for Acute ACL Tear - Full Text View

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. 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	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: Participant, Investigator Primary Purpose: Treatment
Official Title:	Early Anti-inflammatory Treatment in Patients With Acute ACL Tear

Resource links provided by NLM:

MedlinePlus related topics: Tears

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by Christian Lattermann, 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) ]
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 ]
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.


Enrollment:	48
Study Start Date:	March 2013
Study Completion Date:	February 5, 2017
Primary Completion Date:	February 5, 2017 (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 (Child, Adult)
Sexes Eligible for Study:	All
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

Locations


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

Sponsors and Collaborators

Christian Lattermann

Vanderbilt University

Investigators


Principal Investigator:	Christian Lattermann, MD	University of Kentucky, Department of Orthopaedic Surgery

More Information

Publications:

Lattermann C, Jacobs CA, Proffitt Bunnell M, Huston LJ, Gammon LG, Johnson DL, Reinke EK, Huebner JL, Kraus VB, Spindler KP. A Multicenter Study of Early Anti-inflammatory Treatment in Patients With Acute Anterior Cruciate Ligament Tear. Am J Sports Med. 2017 Feb;45(2):325-333. doi: 10.1177/0363546516666818. Epub 2016 Oct 7.

Lattermann C, Jacobs CA, Bunnell MP, Jochimsen KN, Abt JP, Reinke EK, Gammon LG, Huebner JL, Kraus VB, Spindler KP. Logistical challenges and design considerations for studies using acute anterior cruciate ligament injury as a potential model for early posttraumatic osteoarthritis. J Orthop Res. 2017 Mar;35(3):641-650. doi: 10.1002/jor.23329. Epub 2016 Jun 30.


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 6, 2017

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on July 27, 2017

Early Treatment for Acute ACL Tear (AAA)