Can Testosterone Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair
- Registration Number
- NCT04345666
- Lead Sponsor
- Orthopedic Institute, Sioux Falls, SD
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
- Males
- arthroscopic rotator cuff repair is an indicated treatment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Placebos 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). Testosterone group Testosterone cypionate 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).
- Primary Outcome Measures
Name Time Method American Shoulder and Elbow Score 12 months after surgery A validated joint specific patient-determined outcome score (low 0 - 100 high)
Simple Shoulder Test 12 months after surgery A validated joint specific patient-determined outcome score (low 0 - 12 high)
Shoulder Activity Level 12 months after surgery A validated shoulder-specific activity score (low 0 - 20 high)
Single Alpha-Numeric Assessment Evaluation 12 months after surgery A validated general patient-determined outcome score (low 0 - 100 high)
Shoulder Range of Motion 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 12 months after surgery Dynanometrically measured scaption and external rotation strength (Newtons)
- Secondary Outcome Measures
Name Time Method Magnetic resonance imaging shoulder 12 months after surgery MRI
Trial Locations
- Locations (1)
Orthopedic Institute
🇺🇸Sioux Falls, South Dakota, United States