NCT05438914招募中不适用
Subscapularis Repair in Reverse Shoulder Arthroplasty: a Randomized, Controlled, Multicenter, Prospective Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 12
- 主要终点
- Constant-Murley Shoulder Outcome Score
研究概览
简要总结
This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).
详细描述
The primary objective of this study is to evaluate pain and function in patients undergoing RSA with or without subscapularis repair. This primary outcome will be measured by analysis of Constant scores at two years post-operative.
Secondary objectives are to evaluate pain, function and imaging, between the two groups at each applicable time point.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is scheduled to undergo a reverse shoulder arthroplasty procedure using the Arthrex ReversTM system.
- •Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
- •Patient meets FDA cleared indications for reverse shoulder arthroplasty
- •Patient is between 18-100 years old
- •Patient agrees to also be enrolled in the Arthrex Total Shoulder Registry Study
- •Patient has a standard of care pre-operative CT taken within 6 months that has been submitted for Arthrex Virtual Implant Positioning TM (VIP) planning
排除标准
- •Patient has a history of ipsilateral shoulder arthroplasty
- •A history of shoulder septic arthritis
- •A full thickness subscapularis tear
- •An acute or malunited proximal humeral fracture
- •Chronic locked dislocation
- •Rheumatoid arthritis
- •Axillary nerve damage
- •Non-functioning deltoid muscle
- •Glenoid vault deficiency precluding baseplate fixation
- •Infection and neuropathic joints
- •Known or suspected non-compliance, drug or alcohol abuse
- •Patients incapable of judgement or under tutelage
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc.
- •The subject is related to investigator as family members, employees, or other dependent persons
- •Any prior open anterior shoulder surgery that included takedown of the subscapularis tendon or violation of the subscapularis tendon (i.e. Latarjet, Bristow)
结局指标
主要结局
Constant-Murley Shoulder Outcome Score
时间窗: Collected at the 2 year post-op timepoint, and is the primary outcome measure
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
次要结局
- American Shoulder and Elbow Surgeons (ASES) subjective survey(Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.)
- Simple Shoulder Test (SST) questionnaire(Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.)
- Visual Analog Scale (VAS)(Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.)
- Ultrasound(Collected once at either the 6 month, 1 year or 2 year timepoint.)
- Single Assessment Numeric Evaluation score (SANE)(Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.)
- Western Ontario Osteoarthritis of the Shoulder Index (WOOS)(Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.)
- Veterans Rand 12 Item Health Survey (VR-12)(Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.)
- Standard Pre-Operative Form(Collected at the pre-op visit.)
- Return to Work Form(Collected at pre-op, 26 weeks and 1 year.)
- Standard Late Postoperative Form(Collected at the 1 year and 2 year timepoints.)
研究者
研究点 (12)
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