Randomized Controlled Trial of the Use of Doxycycline After Rotator Cuff Repair
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- rotator cuff ultrasound of post-operative shoulder
研究概览
简要总结
The purpose of this study is to examine healing after rotator cuff repair in subjects either treated with Doxycycline or placebo post-operatively.
详细描述
Basic Science small animal model data indicates that matrix metalloproteinase (MMP) inhibition via doxycycline results in improved early rotator cuff repair biomechanics and histology. Rotator cuff repair failure and retear is a significant clinical problem. The effects of MMP inhibition on human rotator cuff tear repair healing and outcomes is unknown, but may potentially improve healing rates and outcomes. Our purpose is to evaluate the effects of early oral doxycycline on healing and outcomes following arthroscopic rotator cuff repair.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •repair of rotator cuff
- •age 18 and above
- •able to swallow capsules
排除标准
- •less than 18
- •unable to read or understand consent form
- •unable to swallow capsules
- •allergy to doxycycline
研究组 & 干预措施
Doxycycline
oral doxycycline, 2 weeks, twice a day,
干预措施: Doxycycline (Drug)
sugar pill
sugar pill, same size, shape, and color as comparator, twice a day for 2 weeks.
干预措施: sugar pill (Drug)
结局指标
主要结局
rotator cuff ultrasound of post-operative shoulder
时间窗: one year
An ultrasound of the post-operative rotator cuff to assess level of healing or defect present.
次要结局
- American Shoulder and Elbow Surgeons score(6 weeks, 3mos, 6mos, 1yr and 2 yr.)
研究者
Aman Dhawan, MD
Assistant Professor of Surgery, Orthopaedics
Milton S. Hershey Medical Center