Early Treatment for Acute ACL Tear

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-02-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Early Anti-inflammatory Treatment in Patients With Acute ACL Tear and Painful Effusions

NCT03429140

Anterior Cruciate Ligament

COMPLETED EARLY_PHASE1

Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery

NCT04246554

ACL Injury Postoperative Pain

COMPLETED PHASE3

Study of RNS60 on Pain and Function After Knee Anterior Cruciate Ligament Surgery

NCT01922427

Anterior Cruciate Ligament Reconstruction

WITHDRAWN PHASE2

Preemptive Analgesia in Cruciate Reconstruction

NCT01017380

Anterior Cruciate Ligament Injury

COMPLETED PHASE3

Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery

NCT04246541

Meniscus Tear, Tibial Pain, Postoperative Postoperative Complications +2 more

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anterior Cruciate Ligament (ACL) Tears

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Kenalog or Placebo

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

Group Type EXPERIMENTAL

Kenalog or placebo

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Kenalog then Placebo

Intervention Type DRUG

Kenalog only

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

Group Type EXPERIMENTAL

Kenalog

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Kenalog or placebo

Intervention Type DRUG

Kenalog then Placebo

Intervention Type DRUG

Kenalog

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

14 Years

Maximum Eligible Age

33 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No