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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
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
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
Orthopedic Institute
Sioux Falls, South Dakota, United States
American Shoulder and Elbow Score
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Time frame: 3 months after surgery
American Shoulder and Elbow Score
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Time frame: 6 months after surgery
American Shoulder and Elbow Score
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Time frame: 12 months after surgery
Simple Shoulder Test
A validated joint specific patient-determined outcome score (low 0 - 12 high)
Time frame: 3 months after surgery
Simple Shoulder Test
A validated joint specific patient-determined outcome score (low 0 - 12 high)
Time frame: 6 months after surgery
Simple Shoulder Test
A validated joint specific patient-determined outcome score (low 0 - 12 high)
Time frame: 12 months after surgery
Single Alpha-Numeric Assessment Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Time frame: 3 months after surgery
Single Alpha-Numeric Assessment Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Time frame: 6 months after surgery
Single Alpha-Numeric Assessment Evaluation
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A validated general patient-determined outcome score (low 0 - 100 high)
Time frame: 12 months after surgery
Shoulder Activity Level
A validated shoulder-specific activity score (low 0 - 20 high)
Time frame: 3 months after surgery
Shoulder Activity Level
A validated shoulder-specific activity score (low 0 - 20 high)
Time frame: 6 months after surgery
Shoulder Activity Level
A validated shoulder-specific activity score (low 0 - 20 high)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months after surgery
Shoulder strength
Dynanometrically measured scaption and external rotation strength (Newtons)
Time frame: 3 months after surgery
Shoulder strength
Dynanometrically measured scaption and external rotation strength (Newtons)
Time frame: 6 months after surgery
Shoulder strength
Dynanometrically measured scaption and external rotation strength (Newtons)
Time frame: 12 months after surgery
Magnetic resonance imaging shoulder
MRI
Time frame: 12 months after surgery