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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.
 
ClinicalTrials.gov Identifier: NCT01692756
Recruitment Status : Completed
First Posted : September 25, 2012
Results First Posted : November 13, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
Vanderbilt University
Information provided by (Responsible Party):
Cale Jacobs, 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 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. Participant Pain Assessment [ Time Frame: Up to seven days ]
    Participants with be given a Visual Analog Scale (VAS) pain assessment questionnaire which scores the participant's perceived pain on a scale of 0-10 were zero is no pain and 10 is the worst pain imaginable. The scale will be administered during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.


Secondary Outcome Measures :
  1. Efficacy of Kenalog to Alleviate Knee Pain [ Time Frame: Up to seven days ]
    The efficacy of Kenalog with be determined using the Knee Injury and Osteoarthritis Outcome Score (KOOS) instrument. Participants will self-report knee pain and function through the KOOS questionnaire during the initial orthopedic consult and during the pre-op assessment prior to surgery, between 1 and 7 days later. The scale scores range from 100 (no symptoms) to zero (extreme symptoms).

  2. Synovial Interleukin-1α (IL-1α) Concentration [ Time Frame: Up to seven days ]
    Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1α concentration using an immunoassay. Data will be presented as the change in IL-1α concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.

  3. Synovial Interleukin-1β (IL-1β) Concentration [ Time Frame: Up to seven days ]
    Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1β concentration using an immunoassay. Data will be presented as the change in IL-1β concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.

  4. Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration [ Time Frame: Up to seven days ]
    Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1ra concentration using an immunoassay. Data will be presented as the change in IL-1ra concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.

  5. Synovial C-terminal Peptide II (CTXII) Concentration [ Time Frame: Up to seven days ]
    Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure CTXII concentration using an immunoassay. Data will be presented as the change in CTXII concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.

  6. Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration [ Time Frame: Up to seven days ]
    Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure COMP concentration using an immunoassay. Data will be presented as the change in COMP concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.

  7. Synovial Glycosaminoglycans (GAG) Concentration [ Time Frame: Up to seven days ]
    Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure GAG concentration using an immunoassay. Data will be presented as the change in GAG concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.

  8. Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration [ Time Frame: Up to seven days ]
    Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure NTX-I concentration using an immunoassay. Data will be presented as the change in NTX-I concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.

  9. Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration [ Time Frame: Up to seven days ]
    Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure TSG-6 concentration using an immunoassay. Data will be presented as the change in TSG-6 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.

  10. Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration [ Time Frame: Up to seven days ]
    Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-1 concentration using an immunoassay. Data will be presented as the change in MMP-1 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.

  11. Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration [ Time Frame: Up to seven days ]
    Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-3 concentration using an immunoassay. Data will be presented as the change in MMP-3 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.

  12. Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration [ Time Frame: Up to seven days ]
    Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-9 concentration using an immunoassay. Data will be presented as the change in MMP-9 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.



Information from the National Library of Medicine

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.


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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
  • Anterior Cruciate Ligament (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 ClinicalTrials.gov identifier (NCT number): NCT01692756


Locations
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United States, Kentucky
UK HeathCare Sports Medicine
Lexington, Kentucky, United States, 40517
Sponsors and Collaborators
Cale Jacobs
Vanderbilt University
Investigators
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Principal Investigator: Christian Lattermann, MD University of Kentucky, Department of Orthopaedic Surgery
  Study Documents (Full-Text)

Documents provided by Cale Jacobs, University of Kentucky:

Publications of Results:
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Responsible Party: Cale Jacobs, Sponsor/Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT01692756    
Other Study ID Numbers: 12-0706
First Posted: September 25, 2012    Key Record Dates
Results First Posted: November 13, 2018
Last Update Posted: December 5, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Pharmaceutical Solutions
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