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Completed

NCT Number: NCT01692756

Early Treatment for Acute ACL Tear

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.

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Key information

Conditions

Anterior Cruciate Ligament (ACL) Tears Lacerations Wounds and Injuries

Age range

14 year–33 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UK HeathCare Sports Medicine

Lexington, Kentucky, 40517, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kenalog or placebo

Drug

Other names: Drug: Kenalog, Other Names:, triamcinolone acetonide injectable suspension, Drug Placebo (for Kenalog), physiologic Saline solution

Kenalog then Placebo

Drug

Other names: Drug: Kenalog, Other Names:, triamcinolone acetonide injectable suspension, Drug Placebo (for Kenalog), physiologic saline solution

kenalog

Drug

Other names: Drug: Kenalog, Other Names:, triamcinolone acetonide injectable suspension

Placebo

Drug

Other names: Drug Placebo (for Kenalog), physiologic saline solution

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cale Jacobs

Other

Collaborators

  • Vanderbilt University

Registry information

Official study title

Early Anti-inflammatory Treatment in Patients With Acute ACL Tear

Acronym: AAA

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2012
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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