Early Treatment for Acute ACL Tear

NCT01692756 | Completed Phase 2 Results DMC

• 1 other identifier: 12-0706
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament (ACL) Tears

Outcome Measures

Primary Outcomes (1)

• Participant Pain Assessment

  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.

  Up to seven days

Secondary Outcomes (12)

• Efficacy of Kenalog to Alleviate Knee Pain

  Up to seven days

• Synovial Interleukin-1α (IL-1α) Concentration

  Up to seven days

• Synovial Interleukin-1β (IL-1β) Concentration

  Up to seven days

• Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration

  Up to seven days

• Synovial C-terminal Peptide II (CTXII) Concentration

  Up to seven days

Study Arms (4)

Kenalog or Placebo

EXPERIMENTAL

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Drug: Kenalog or placebo

Kenalog then placebo

EXPERIMENTAL

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

Kenalog only

EXPERIMENTAL

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Drug: Kenalog

Placebo

PLACEBO COMPARATOR

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Drug: Placebo

Interventions

Kenalog or placebo DRUG

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

Kenalog or Placebo

Kenalog then Placebo DRUG

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

Kenalog then placebo

Kenalog DRUG

Also known as: Drug: Kenalog, Other Names:, triamcinolone acetonide injectable suspension

Kenalog only

Placebo DRUG

Also known as: Drug Placebo (for Kenalog), physiologic saline solution

Placebo

Eligibility Criteria

• Age: 14 Years - 33 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• currently participating in sporting activities
• Normal contralateral knee status
• Anterior Cruciate Ligament (ACL) injury occurred while playing a sporting activity

You may not qualify if:

• 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

Sponsors & Collaborators

• Cale Jacobs: lead
• Vanderbilt University: collaborator

Study Sites (1)

UK HeathCare Sports Medicine

Lexington, Kentucky, 40517, United States

Location

Related Publications (3)

• 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.

  PMID: 28146402 RESULT

• 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.

  PMID: 27279368 RESULT

• King JD, Rowland G, Villasante Tezanos AG, Warwick J, Kraus VB, Lattermann C, Jacobs CA. Joint Fluid Proteome after Anterior Cruciate Ligament Rupture Reflects an Acute Posttraumatic Inflammatory and Chondrodegenerative State. Cartilage. 2020 Jul;11(3):329-337. doi: 10.1177/1947603518790009. Epub 2018 Jul 22.

  PMID: 30033738 DERIVED

MeSH Terms

Conditions

Lacerations

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Cale Jacobs, ATC, PhD
• Organization: Univerisity of Kentucky

Kycartilagedoc@gmail.com

8592183065

Study Officials

• Christian Lattermann, MD

  University of Kentucky, Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor/Investigator

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 25, 2012
• Study Start: March 1, 2013
• Primary Completion: February 5, 2017
• Study Completion: February 5, 2017
• Last Updated: December 5, 2018
• Results First Posted: November 13, 2018

Record last verified: 2018-11

Locations

US (1)