Testosterone Administration and ACL Reconstruction in Men

NCT01595581 | Completed Phase 3 Results

• 1 other identifier: HS-11-00649
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Atrophy; ACL Reconstruction; Trauma; Osteoarthritis

Keywords

Testosterone; ACL Reconstruction; Clinical outcomes; Lean mass; Strength; Muscle atrophy

Outcome Measures

Primary Outcomes (1)

• Changes in Lean Mass

  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 Outcomes (2)

• KOOS Scores

  6 weeks, 12 weeks, 24 weeks post surgery

• Strength

  6, 12, and 24 weeks post surgery

Study Arms (2)

Testosterone

EXPERIMENTAL

Weekly injection of testosterone enanthate 200mg

Drug: Testosterone

Placebo

PLACEBO COMPARATOR

Weekly injection of saline as the placebo

Drug: Placebo

Interventions

Testosterone DRUG

8 weeks of testosterone administration beginning 2 weeks before ACL surgery

Also known as: testosterone enanthate

Testosterone

Placebo DRUG

8 weeks of saline administration beginning 2 weeks before ACL surgery

Also known as: saline

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• Boston University: collaborator
• University of Oregon: collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (2)

• 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.

  PMID: 28840147 DERIVED

• 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.

  PMID: 25481088 DERIVED

MeSH Terms

Conditions

Muscular Atrophy; Wounds and Injuries; Osteoarthritis

Interventions

Testosterone; testosterone enanthate; Sodium Chloride

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Edward Schroeder
• Organization: University of Southern California

eschroed@usc.edu

323-442-2498

Study Officials

• Todd Schroeder, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Physical Therapy

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 10, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 2, 2022
• Results First Posted: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)