Testosterone Administration and ACL Reconstruction in Men (TACL)

February 8, 2022 updated by: Todd Schroeder, University of Southern California

The Effects of Acute Testosterone Administration in Men on Muscle Mass, Strength, and Physical Function Following ACL Reconstructive Surgery

This study is being done to test whether taking testosterone can prevent loss of muscle mass and strength due to anterior cruciate ligament (ACL) reconstructive surgery. Testosterone is the principal male sex hormone and an anabolic (muscle promoting) steroid. It is essential for the development of male reproductive tissues and promotes increased muscle, bone mass, and the growth of body hair.

The investigators hope to learn whether testosterone given before and after ACL reconstructive surgery will increase muscle mass and strength and potentially improve recovery time following surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Overall Objective: The overall objective of this study is to determine if 8 weeks of testosterone first administered 2 weeks prior to surgery, can improve the outcome of anterior cruciate ligament (ACL) reconstruction.

Overall Hypothesis: Standard-of-care rehabilitation with the addition of testosterone administration will augment muscle mass, strength, and physical function following ACL reconstructive surgery compared to standard rehabilitation alone.

Significance: Muscle mass and strength are greatly reduced following ACL surgery. The investigators hypothesize that administration of testosterone will minimize these reductions or potentially increase muscle mass and strength. In doing so, testosterone may hasten a patient's return to physical activity. If testosterone improves recovery after ACL surgery, the same treatment may be used for other injuries that involve trauma and muscle atrophy. Furthermore, this study will examine the effect of trauma with or without testosterone on myogenic regulators in muscle tissue taken during ACL surgery-providing possible mechanistic insights for the clinical outcomes.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • A complete ACL tear as visualized on MRI
  • The ACL injury can be either "isolated" or combined with one or several of the following injuries visualized on MRI and/or arthroscopy:
  • a meniscus tear that is either left untreated or treated with a partial resection
  • a small, stable meniscus tear treated with fixation, but with the fixation not interfering with the rehabilitation protocol
  • cartilage changes verified on MRI with an arthroscopically determined intact surface.
  • A radiographic examination with normal joint status or combined with either one of the following findings:
  • a small-avulsed fragment located laterally, usually described as a Segond fracture, JSN grade 1 or osteophytes grade 1 as determined by the OARSI atlas15

Exclusion Criteria:

  • Previous major knee injury or knee surgery
  • Associated posterior cruciate ligament (PCL) or medical collateral ligament (MCL) injury grade III
  • Concomitant severe injury to contra-lateral knee
  • Injury to the lateral/posterolateral ligament complex with significantly increased laxity
  • Unstable longitudinal meniscus tear that requires repair and where the following postoperative treatment (we.e. bracing and limited range of motion) interferes with the rehabilitation protocol
  • Bi-compartmental extensive meniscus resections
  • Cartilage injury representing a full thickness loss down to bone
  • Total rupture of MCL/LCL as visualized on MRI.
  • History of deep vein thrombosis (DVT) or a disorder of the coagulative system
  • Claustrophobia
  • Prior or current use of anabolic steroids
  • General systemic disease affecting physical function
  • Chromosomal disorders
  • Medications that interfere with testosterone production or function, including but not limited to 5α-reductase inhibitors
  • Any other condition or treatment interfering with the completion of the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Testosterone
Weekly injection of testosterone enanthate 200mg
Drug: Testosterone
8 weeks of testosterone administration beginning 2 weeks before ACL surgery
Other Names:
  • testosterone enanthate
Placebo Comparator: Placebo
Weekly injection of saline as the placebo
Drug: Placebo
8 weeks of saline administration beginning 2 weeks before ACL surgery
Other Names:
  • saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Lean Mass
Time Frame: 6, 12, and 24 weeks post operative
Relative changes in lean mass from 2 weeks prior to surgery to 6 weeks, 12 weeks, and 24 weeks following surgery between the two groups.
6, 12, and 24 weeks post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS Scores
Time Frame: 6 weeks, 12 weeks, 24 weeks post surgery

Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) from 2 weeks prior to surgery to 6, 12, and 24 weeks post surgery.

KOOS is scored from 0 to 100 with 0 representing extreme knee problems and 100 representing normal knee function.
6 weeks, 12 weeks, 24 weeks post surgery
Strength
Time Frame: 6, 12, and 24 weeks post surgery
Changes in muscle strength from the start of rehabilitation to 6, 12, and 24 weeks following surgery between the two groups in the injured limb.
6, 12, and 24 weeks post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

Boston University
University of Oregon

Investigators

  • Principal Investigator: Todd Schroeder, PhD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (Estimate)

May 10, 2012

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-11-00649

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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