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Testosterone Administration and ACL Reconstruction in Men (TACL)

Primary Purpose

Muscle Atrophy, ACL Reconstruction, Trauma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Testosterone
Placebo
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Atrophy focused on measuring Testosterone, ACL Reconstruction, Clinical outcomes, Lean mass, Strength, Muscle atrophy

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Testosterone

Placebo

Arm Description

Weekly injection of testosterone enanthate 200mg

Weekly injection of saline as the placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

KOOS Scores
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.
Strength
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.

Full Information

First Posted
May 8, 2012
Last Updated
February 8, 2022
Sponsor
University of Southern California
Collaborators
Boston University, University of Oregon
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1. Study Identification

Unique Protocol Identification Number
NCT01595581
Brief Title
Testosterone Administration and ACL Reconstruction in Men
Acronym
TACL
Official Title
The Effects of Acute Testosterone Administration in Men on Muscle Mass, Strength, and Physical Function Following ACL Reconstructive Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Boston University, University of Oregon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Atrophy, ACL Reconstruction, Trauma, Osteoarthritis
Keywords
Testosterone, ACL Reconstruction, Clinical outcomes, Lean mass, Strength, Muscle atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Testosterone
Arm Type
Experimental
Arm Description
Weekly injection of testosterone enanthate 200mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Weekly injection of saline as the placebo
Intervention Type
Drug
Intervention Name(s)
Testosterone
Other Intervention Name(s)
testosterone enanthate
Intervention Description
8 weeks of testosterone administration beginning 2 weeks before ACL surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
saline
Intervention Description
8 weeks of saline administration beginning 2 weeks before ACL surgery
Primary Outcome Measure Information:
Title
Changes in Lean Mass
Description
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.
Time Frame
6, 12, and 24 weeks post operative
Secondary Outcome Measure Information:
Title
KOOS Scores
Description
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.
Time Frame
6 weeks, 12 weeks, 24 weeks post surgery
Title
Strength
Description
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.
Time Frame
6, 12, and 24 weeks post surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Schroeder, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28840147
Citation
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.
Results Reference
derived
PubMed Identifier
25481088
Citation
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.
Results Reference
derived

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Testosterone Administration and ACL Reconstruction in Men

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