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| Name | Class |
|---|---|
| Boston University | OTHER |
| University of Oregon | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone | Experimental | Weekly injection of testosterone enanthate 200mg |
|
| Placebo | Placebo Comparator | Weekly injection of saline as the placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone | Drug | 8 weeks of testosterone administration beginning 2 weeks before ACL surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks, 12 weeks, 24 weeks post surgery |
| Strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Schroeder, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28840147 | Derived | 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. | |
| 25481088 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Testosterone | Testosterone: 8 weeks supraphysiologic dose testosterone enanthate |
| FG001 | Placebo | Saline: Placebo for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone | Testosterone: 8 weeks 200mg dose testosterone enanthate |
| BG001 | Placebo | Saline: Placebo for 8 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Region of enrollment from the Los Angeles area. | Posted | Mean | Standard Deviation | kg | 6, 12, and 24 weeks post operative |
|
Trough the study completion (24-weeks).
All subjects were monitored/assessed for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Testosterone | Testosterone: 8 weeks supraphysiologic dose testosterone enanthate |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward Schroeder | University of Southern California | 323-442-2498 | eschroed@usc.edu |
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| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D014947 | Wounds and Injuries |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| C004648 | testosterone enanthate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo | Drug | 8 weeks of saline administration beginning 2 weeks before ACL surgery |
|
|
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. |
| 6, 12, and 24 weeks post surgery |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Recruited from the Los Angeles area | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | 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. | Region of enrollment from the Los Angeles area. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks, 12 weeks, 24 weeks post surgery |
|
|
|
| Secondary | 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. | Region of enrollment from the Los Angeles area. | Posted | Mean | Standard Deviation | Nm | 6, 12, and 24 weeks post surgery |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Placebo | Saline: Placebo for 8 weeks | 0 | 7 | 0 | 7 | 0 | 7 |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| 24 weeks post op |
|
| 24 weeks post op |
|