Title
Can Testosterone Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair
A Randomized, Blinded Controlled Trial to Determine if Testosterone Can Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair
Phase
Phase 2/Phase 3Lead Sponsor
Orthopedic Institute, Sioux Falls, SDStudy Type
InterventionalStatus
WithdrawnIndication/Condition
Rotator Cuff TearsIntervention/Treatment
Testosterone cypionate ...Study Participants
0The 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.
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
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).
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).
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
