Rotator Cuff Tears
Conditions
Keywords
arthroscopic rotator cuff repair, testosterone, accelerate recovery from surgery
Brief summary
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
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.
Interventions
DRUGTestosterone cypionate
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
DRUGPlacebos
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
Sponsors
Orthopedic Institute, Sioux Falls, SD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The patient and the primary investigator will be blinded to the treatment allocation. The study coordinator will be unblinded.
Intervention model description
Randomized, double-blinded, placebo controlled model
Eligibility
Sex/Gender
MALE
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Single Alpha-Numeric Assessment Evaluation | 3 months after surgery | A validated general patient-determined outcome score (low 0 - 100 high) |
| American Shoulder and Elbow Score | 3 months after surgery | A validated joint specific patient-determined outcome score (low 0 - 100 high) |
| Simple Shoulder Test | 3 months after surgery | A validated joint specific patient-determined outcome score (low 0 - 12 high) |
| Shoulder strength | 3 months after surgery | Dynanometrically measured scaption and external rotation strength (Newtons) |
| Shoulder Activity Level | 3 months after surgery | A validated shoulder-specific activity score (low 0 - 20 high) |
| Shoulder Range of Motion | 3 months after surgery | Goniometrically-measured (in degrees) Flexion, extension, abduction, external rotation, abducted external rotation, abducted internal rotation, internal rotation behind the back |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Magnetic resonance imaging shoulder | 12 months after surgery | MRI |
Countries
United States
Outcome results
None listed