A Randomized, Blinded Controlled Trial to Determine if Testosterone Can Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair
Overview
- Phase
- Phase 2
- Intervention
- Testosterone cypionate
- Conditions
- Rotator Cuff Tears
- Sponsor
- Orthopedic Institute, Sioux Falls, SD
- Locations
- 1
- Primary Endpoint
- American Shoulder and Elbow Score
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
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.
Investigators
Keith Baumgarten
Orthopedic Surgeon - Physician Scientis
Orthopedic Institute, Sioux Falls, SD
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
Testosterone group
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).
Intervention: Testosterone cypionate
Placebo group
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).
Intervention: Placebos
Outcomes
Primary Outcomes
American Shoulder and Elbow Score
Time Frame: 12 months after surgery
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Simple Shoulder Test
Time Frame: 12 months after surgery
A validated joint specific patient-determined outcome score (low 0 - 12 high)
Shoulder Activity Level
Time Frame: 12 months after surgery
A validated shoulder-specific activity score (low 0 - 20 high)
Single Alpha-Numeric Assessment Evaluation
Time Frame: 12 months after surgery
A validated general patient-determined outcome score (low 0 - 100 high)
Shoulder Range of Motion
Time Frame: 12 months after surgery
Goniometrically-measured (in degrees) Flexion, extension, abduction, external rotation, abducted external rotation, abducted internal rotation, internal rotation behind the back
Shoulder strength
Time Frame: 12 months after surgery
Dynanometrically measured scaption and external rotation strength (Newtons)
Secondary Outcomes
- Magnetic resonance imaging shoulder(12 months after surgery)