Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in condition of the shoulder as assessed by American Shoulder and Elbow Surgeon (ASES) Score
研究概览
简要总结
This study will compare arthroscopic transosseous versus anchored rotator cuff repairs in terms of clinical outcomes, rotator cuff integrity, and cost-effectiveness. With the collection of patient-reported outcomes the health of patients undergoing each rotator cuff repair technique will be assessed. The aims of this study will be achieved through a clinical randomized controlled trial and a cost-effectiveness analysis.
详细描述
Study Design: After the decision to proceed with arthroscopic rotator cuff repair, patients will be asked to participate in this prospective randomized clinical trial.
Study Procedures:
Before Surgery: The Informed Consent process will be completed prior to any data collection. Consent will be completed after explanation of each treatment group and the data to be collected. Baseline and demographic data will be collected prior to surgery:
Randomization: Subjects will be randomized prior to surgery into one of the two rotator cuff repair technique groups using REDCap software. Randomization will be stratified by gender.
Patient Visits:
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults age 18-75 years old
- •Full thickness rotator cuff tears of any size (documented by MRI or ultrasound)
- •Patients planning surgical repair with Dr. Uma Srikumaran (PI of this study) at Johns Hopkins Shoulder Service (Columbia, Odenton Clinic sites; Howard County General Hospital/Bayview/Johns Hopkins Hospital operative sites)
排除标准
- •Patients with partial tears, massive rotator cuff tears that are irreparable, isolated subscapularis tears, and associated pathology (advanced degenerative changes)
- •Patients undergoing revision rotator cuff tears will be excluded.
研究组 & 干预措施
Tensor Tunnler
The Tensor Tunneler (Chattanooga, TN) will be used to create the bone tunnels during the arthroscopic procedure. This is an FDA approved device and is used currently in routine clinical practice.
干预措施: Tensor Tunnler (Device)
Smith and Nephew PEEK Helicoil Anchor
The anchors used in this trial are FDA approved and are used currently in routine clinical practice (Anchor Rotator Cuff Repair).
干预措施: Anchor Rotator Cuff Repair (Procedure)
结局指标
主要结局
Change in condition of the shoulder as assessed by American Shoulder and Elbow Surgeon (ASES) Score
时间窗: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
10 separate questions is scored on an ordinal scale from 0-3 for a maximal raw functional score of 30 (no difficulties).
次要结局
- Implant Cost(Within 1 month after surgery)
- Change in Strength Testing(Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery)
- Change in shoulder pain as assessed by Visual Analog Pain Score(Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery)
- Change in Range of Motion (ROM)(Before surgery, within 1 month after surgery, 3 months, 6 months, 1 year)
- Change in quality of life as assessed by the Western Ontario Rotator Cuff (WORC) Index(Before surgery, 1 year after surgery, 2 years after surgery)
- Change in health related quality of life as assessed by Short-Form Six-Dimension (SF-6D)(Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery)