Subacromial Bursa Re-Implantation After Rotator Cuff Repair - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Change in range of motion
研究概览
简要总结
The purpose of this study is to evaluate clinical outcomes, structural integrity, and tendon organization after rotator cuff repair with and without subacromial bursa implantation and to further co-existing research studies performed at The University Of Texas Health Science Center of Houston (UT Health) on Ultrashort Time to Echo-Magnetic Imaging Resonance(UTE-MRI) techniques and their implication for rotator cuff analysis.
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
- 25 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present with rotator cuff tears requiring arthroscopic repair as confirmed by a medical expert
- •Are able to provide informed consent
- •Can commit to study follow-up visits or procedures
排除标准
- •Are unable to provide informed consent
- •Have additional ipsilateral shoulder complications that will inhibit standard of care treatment and rehabilitation
- •Have active infection at operative site
- •Have active systemic infection
- •Chronic inflammatory condition such as rheumatoid arthritis or lupus
- •Has had a corticosteroid injection to the affected shoulder within the six weeks prior to surgery
- •Have had prior surgical interventions in the past that have modified the existing natural anatomical arrangement of the rotator cuff/shoulder.
- •Non-English speaker
结局指标
主要结局
Change in range of motion
时间窗: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
range of motion will be measured using a goniometer
Change in pain as assessed by the Visual Analog Scale (VAS)
时间窗: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
The VAS is scored form 0-10, 0 being no pain and 10 being worst pain
Change in strength of shoulder
时间窗: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
shoulder strength will be measured using handheld dynamometer
Change in functional limitations of shoulder as measured by the Simple Shoulder Test(SST)
时间窗: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
The SST consists of 12 questions with dichotomous (yes/ no) response options. For each question, the patients indicate that they are able or are not able to do the activity. The scores range from 0 (worst) to 12(best)
Change in pain of shoulder as measured by the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
时间窗: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
This is scored form 0-100,lower score means worse pain
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Tests (CATs)
时间窗: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
PROMIS CAT-PF is scored on a scale from 20-80, where a higher number indicates higher function
次要结局
- Number of participants with improvement in tendon organization as assessed using quantitative postoperative ultrashort magnetic resonance imaging (UTE-MRI) using the same MRI scans from the 6- and 12-month time points.(12 months post surgery)
- Number of participants with improvement in structural integrity as assessed by postoperative MRI(12 months post surgery)
研究者
James M. Gregory
Assistant Professor
The University of Texas Health Science Center, Houston