Muscle AtrophyPhase 3TACLNCT01595581
Testosterone Administration and ACL Reconstruction in Men
A Phase 3 study testing Testosterone in people with Muscle Atrophy and ACL Reconstruction, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Muscle Atrophy, ACL Reconstruction, Trauma
- What is being tested?
- Testosterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to May 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: 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.
Read the 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
- Being tested
- Testosterone, Placebo
- Keywords
- Testosterone, ACL Reconstruction, Clinical outcomes, Lean mass, Strength, Muscle atrophy
- Medical subject headings
- Muscular Atrophy, Wounds and Injuries, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Also called testosterone enanthate
8 weeks of testosterone administration beginning 2 weeks before ACL surgery
PlaceboDrug
Also called saline
8 weeks of saline administration beginning 2 weeks before ACL surgery
| Study group | Role | What they receive |
|---|---|---|
| Testosterone | Experimental | Weekly injection of testosterone enanthate 200mg Receives: Drug: Testosterone |
| Placebo | Placebo comparator | Weekly injection of saline as the placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6, 12, and 24 weeks post operative
Secondary outcomes (2)
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.
Measured: 6 weeks, 12 weeks, 24 weeks post surgery
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.
Measured: 6, 12, and 24 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, University of Oregon
- Responsible party
- Principal investigator, Todd Schroeder, University of Southern California
- Investigators
- Todd Schroeder, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595581
- Sponsor's protocol ID
- HS-11-00649
- Acronym
- TACL
- Status last verified
- Feb 2022
- First submitted
- 8 May 2012
- Last updated
- 2 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28840147Wu 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.
PubMed 25481088
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acute Testosterone Administration in Men on Muscle Mass, Strength, and Physical Function Following ACL Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT01595581
- Acronym / sponsor ID
- TACL / HS-11-00649
- Conditions
- Muscle Atrophy, ACL Reconstruction, Trauma, Osteoarthritis
- Keywords
- Testosterone, ACL Reconstruction, Clinical outcomes, Lean mass, Strength, Muscle atrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Boston University, University of Oregon
- Study start
- Apr 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Posted 2 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone | Experimental | Drug: TestosteroneWeekly injection of testosterone enanthate 200mg |
| Placebo | Placebo comparator | Drug: PlaceboWeekly injection of saline as the placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TestosteroneAlso: testosterone enanthate8 weeks of testosterone administration beginning 2 weeks before ACL surgery | Drug | Testosterone |
| PlaceboAlso: saline8 weeks of saline administration beginning 2 weeks before ACL surgery | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
KOOS Scores
Time frame: 6 weeks, 12 weeks, 24 weeks post surgery
Strength
Time frame: 6, 12, and 24 weeks post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28840147Wu 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.
- Derived from this study: PubMed 25481088Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Schroeder, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Testosterone in people with Muscle Atrophy and ACL Reconstruction, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Lean Mass (time frame: 6, 12, and 24 weeks post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01595581, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.