A Randomized, Blinded Controlled Trial to Determine if Testosterone Can Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- American Shoulder and Elbow Score
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The patient and the primary investigator will be blinded to the treatment allocation. The study coordinator will be unblinded.
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •arthroscopic rotator cuff repair is an indicated treatment
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Testosterone cypionate (Drug)
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).
干预措施: Placebos (Drug)
结局指标
主要结局
American Shoulder and Elbow Score
时间窗: 12 months after surgery
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Simple Shoulder Test
时间窗: 12 months after surgery
A validated joint specific patient-determined outcome score (low 0 - 12 high)
Shoulder Activity Level
时间窗: 12 months after surgery
A validated shoulder-specific activity score (low 0 - 20 high)
Single Alpha-Numeric Assessment Evaluation
时间窗: 12 months after surgery
A validated general patient-determined outcome score (low 0 - 100 high)
Shoulder Range of Motion
时间窗: 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
时间窗: 12 months after surgery
Dynanometrically measured scaption and external rotation strength (Newtons)
次要结局
- Magnetic resonance imaging shoulder(12 months after surgery)
研究者
Keith Baumgarten
Orthopedic Surgeon - Physician Scientis
Orthopedic Institute, Sioux Falls, SD