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 |
Recruitment Status :
Completed
First Posted : September 25, 2012
Results First Posted : November 13, 2018
Last Update Posted : December 5, 2018
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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 |
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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 : | 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 |

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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- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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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
- 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

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 |
Documents provided by Cale Jacobs, University of Kentucky:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
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 |