Randomized Trial Comparing A Novel Sling With A Traditional Abduction Sling After Shoulder Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Patient choice of type of sling to utilize from postoperative days 29-42
研究概览
简要总结
The objective of this study is to determine if the novel shoulder sling has higher patient satisfaction compared to a traditional, abduction sling with at least equivalent postoperative outcomes after arthroscopic rotator cuff repair and total shoulder arthroplasty.
详细描述
Specific Aim I:
To determine if patients undergoing arthroscopic rotator cuff repair prefer the traditional abduction sling vs the novel sling.
Specific Aim II:
To determine if patients undergoing total shoulder arthroplasty prefer the traditional abduction sling vs the novel sling.
Specific Aim III:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing arthroscopic rotator cuff repair and anatomic total shoulder arthroplasty
- •Dominant extremity undergoing surgery
排除标准
- •Patients undergoing revision surgery
- •Patients with a history of significant cervical spine disease, peripheral neuropathy, or concomitant wrist or elbow disorders
- •Patients that do not understand English
- •Patients unwilling to participate or follow up for the study protocols
结局指标
主要结局
Patient choice of type of sling to utilize from postoperative days 29-42
时间窗: 6 weeks after surgery
Categorical variable of which sling they preferred to use for the last two weeks of their 6 week postoperative immobilization period
Sling satisfaction survey
时间窗: 12 months after surgery
a novel, sling satisfaction score (SSS) \[scale 0= best to 10=worst\] utilizing a number-based visual analog scale will be utilized to assess baseline characteristics of common symptoms that have been attributed to sling use
次要结局
- American Shoulder and Elbow Surgeons Score(12 months after surgery)
- Shoulder Activity Level(12 months after surgery)
- Single Assessment Numeric Evaluation(12 months after surgery)
研究者
Keith Baumgarten
Principal Investigator
Orthopedic Institute, Sioux Falls, SD