Phase 3
Completed N=14
Testosterone Administration and ACL Reconstruction in Men
Source: ClinicalTrials.gov NCT01595581 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Changes in Lean Mass — 2.8; -0.1; 2.16; 0.01 kg — p=0.35
◆ Published Evidence
Established
24citations · ~3 / year
Perioperative Testosterone Supplementation Increases Lean Mass in Healthy Men Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial.
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.
Linked Publications (2)
-
Perioperative Testosterone Supplementation Increases Lean Mass in Healthy Men Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial.
-
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Lean Mass |
2.8; -0.1; 2.16; 0.01; 2.13; 1.05 | 0.35 |
| SECONDARY KOOS Scores |
63.2; 65.5; 76.7; 73.2; 84; 86.6 | — |
| SECONDARY Strength |
-53.5; -33.4; -18.3; -6.6; 19.2; 19.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01595581) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.