Early Treatment for Acute ACL Tear (AAA)
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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. |
| ClinicalTrials.gov Identifier: NCT01692756 |
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Recruitment Status :
Completed
First Posted : September 25, 2012
Last Update Posted : February 8, 2017
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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 |
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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Kenalog or Placebo
Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.
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Drug: Kenalog or placebo
Other Names:
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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.
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Drug: Kenalog then Placebo
Other Names:
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Experimental: Kenalog only
Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®
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Drug: Kenalog
Other Names:
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Placebo Comparator: Placebo
subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.
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Drug: Placebo
Other Names:
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- 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
- 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.
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, Learn About Clinical Studies.
| 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
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 ClinicalTrials.gov identifier (NCT number): NCT01692756
| United States, Kentucky | |
| UK HeathCare Sports Medicine | |
| Lexington, Kentucky, United States, 40517 | |
| Principal Investigator: | Christian Lattermann, MD | University of Kentucky, Department of Orthopaedic Surgery |
Publications of Results:
| Responsible Party: | Christian Lattermann, Sponsor/Investigator, University of Kentucky |
| ClinicalTrials.gov 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:
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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 |