Can Testosterone Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair

Study Overview
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Brief Summary
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The objective of this study is to determine if treating patients undergoing arthroscopic rotator cuff repair with testosterone will allow patients to accelerate their recovery time after surgery.

Detailed Description
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Specific Aim I: To determine if testosterone treatment would provide superior patient-determined quality-of-life and activity scores in patients undergoing arthroscopic rotator cuff repair compared to a control group at 3 months after surgery. Specific Aim II: To determine if testosterone treatment would allow for greater postoperative strength improvements in patients undergoing arthroscopic rotator cuff repair compared to a control group at 3 months after surgery. Specific Aim III: To determine if testosterone treatment would allow for greater postoperative range of motion improvements in patients undergoing arthroscopic rotator cuff repair compared to a control group at 3 months after surgery. Specific Aim IV: To determine if the potentially higher activity levels allowed by the testosterone treatment would affect the success of rotator cuff healing as determined by magnetic resonance imaging at one year after arthroscopic rotator cuff repair. The hypothesis of this study was that testosterone treatment of patients undergoing arthroscopic rotator cuff repair would allow patients to achieve 1) better quality-of-life and higher activity levels as determined by patient-determined outcome scores, 2) greater improvements in strength, and 3) greater improvements in range of motion at three months after surgery as compared to the control group. In addition, the authors hypothesize that there would be equivalent healing rates at one year after rotator cuff repair as determined by magnetic resonance imaging between the testosterone group and the control group.

Official Title
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A Randomized, Blinded Controlled Trial to Determine if Testosterone Can Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Drug: Testosterone cypionate
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males arthroscopic rotator cuff repair is an indicated treatment Exclusion Criteria: female patients irreparable rotator cuff tears tears requiring margin convergence repair atrophy of the rotator cuff greater than stage II as determined by the modified Goutallier staging system revision rotator cuff repair inflammatory arthritis adhesive capsulitis significant cervical pain or radiculopathy history of prostate cancer history of benign prostatic hypertrophy history of heart failure history of obstructive sleep apnea history of polycythemia history of venous thromboembolism or inherited thrombophilia

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blinded, placebo controlled model
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testosterone group<br>20 patients will receive a 200 mg testosterone cyprionate intramuscular injection weekly with the first dose started two weeks prior to surgery and the last dose injected at 6 weeks after surgery (9 doses). | Drug: Testosterone cypionate<br>* The intervention of this study is to treat patients to either 1) testosterone cypionate or 2) placebo (sterile saline) to determine if there is a difference in recovery times after arthroscopic rotator cuff repair<br>|
| Placebo Comparator: Placebo group<br>20 patients will receive a sterile saline intramuscular injection weekly with the first dose started two weeks prior to surgery and the last dose injected at 6 weeks after surgery (9 doses). | Drug: Placebos<br>* The intervention of this study is to treat patients to either 1) testosterone cypionate or 2) placebo (sterile saline) to determine if there is a difference in recovery times after arthroscopic rotator cuff repair<br>* Other names: Sterile saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Score | A validated joint specific patient-determined outcome score (low 0 - 100 high) | 3 months after surgery | 
| American Shoulder and Elbow Score | A validated joint specific patient-determined outcome score (low 0 - 100 high) | 6 months after surgery | 
| American Shoulder and Elbow Score | A validated joint specific patient-determined outcome score (low 0 - 100 high) | 12 months after surgery | 
| Simple Shoulder Test | A validated joint specific patient-determined outcome score (low 0 - 12 high) | 3 months after surgery | 
| Simple Shoulder Test | A validated joint specific patient-determined outcome score (low 0 - 12 high) | 6 months after surgery | 
| Simple Shoulder Test | A validated joint specific patient-determined outcome score (low 0 - 12 high) | 12 months after surgery | 
| Single Alpha-Numeric Assessment Evaluation | A validated general patient-determined outcome score (low 0 - 100 high) | 3 months after surgery | 
| Single Alpha-Numeric Assessment Evaluation | A validated general patient-determined outcome score (low 0 - 100 high) | 6 months after surgery | 
| Single Alpha-Numeric Assessment Evaluation | A validated general patient-determined outcome score (low 0 - 100 high) | 12 months after surgery | 
| Shoulder Activity Level | A validated shoulder-specific activity score (low 0 - 20 high) | 3 months after surgery | 
| Shoulder Activity Level | A validated shoulder-specific activity score (low 0 - 20 high) | 6 months after surgery | 
| Shoulder Activity Level | A validated shoulder-specific activity score (low 0 - 20 high) | 12 months after surgery | 
| Shoulder Range of Motion | Goniometrically-measured (in degrees) Flexion, extension, abduction, external rotation, abducted external rotation, abducted internal rotation, internal rotation behind the back | 3 months after surgery | 
| Shoulder Range of Motion | Goniometrically-measured (in degrees) Flexion, extension, abduction, external rotation, abducted external rotation, abducted internal rotation, internal rotation behind the back | 6 months after surgery | 
| Shoulder Range of Motion | Goniometrically-measured (in degrees) Flexion, extension, abduction, external rotation, abducted external rotation, abducted internal rotation, internal rotation behind the back | 12 months after surgery | 
| Shoulder strength | Dynanometrically measured scaption and external rotation strength (Newtons) | 3 months after surgery | 
| Shoulder strength | Dynanometrically measured scaption and external rotation strength (Newtons) | 6 months after surgery | 
| Shoulder strength | Dynanometrically measured scaption and external rotation strength (Newtons) | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnetic resonance imaging shoulder | MRI | 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arthroscopic rotator cuff repair, testosterone, accelerate recovery from surgery