Testosterone Administration and ACL Reconstruction in Men

NCT ID: NCT01595581

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-05-31

Brief Summary

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.

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.

Conditions

Muscle Atrophy; ACL Reconstruction; Trauma; Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Testosterone

Weekly injection of testosterone enanthate 200mg

Group Type: EXPERIMENTAL

Testosterone

Intervention Type: DRUG

8 weeks of testosterone administration beginning 2 weeks before ACL surgery

Placebo

Weekly injection of saline as the placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

8 weeks of saline administration beginning 2 weeks before ACL surgery

Interventions

Testosterone

8 weeks of testosterone administration beginning 2 weeks before ACL surgery

Intervention Type: DRUG

Placebo

8 weeks of saline administration beginning 2 weeks before ACL surgery

Intervention Type: DRUG

Other Intervention Names

testosterone enanthate; saline

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: collaborator

University of Oregon

OTHER

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Todd Schroeder

Assistant Professor of Clinical Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Todd Schroeder, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

University of Southern California

Los Angeles, California, United States

Countries

United States

References

Wu B, Lorezanza D, Badash I, Berger M, Lane C, Sum JC, Hatch GF 3rd, Schroeder ET. Perioperative Testosterone Supplementation Increases Lean Mass in Healthy Men Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Orthop J Sports Med. 2017 Aug 9;5(8):2325967117722794. doi: 10.1177/2325967117722794. eCollection 2017 Aug.

Reference Type: DERIVED

PMID: 28840147 (View on PubMed)

Wu BW, Berger M, Sum JC, Hatch GF 3rd, Schroeder ET. Randomized control trial to evaluate the effects of acute testosterone administration in men on muscle mass, strength, and physical function following ACL reconstructive surgery: rationale, design, methods. BMC Surg. 2014 Dec 6;14:102. doi: 10.1186/1471-2482-14-102.

Reference Type: DERIVED

PMID: 25481088 (View on PubMed)

Other Identifiers

HS-11-00649

Identifier Type: -

Identifier Source: org_study_id