Sling vs No Sling After Reverse Total Shoulder Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants who develop any kind of postoperative complication
研究概览
简要总结
This study involves patients who will be undergoing a reverse total shoulder replacement at Duke University. 100 eligible will be randomly assigned into one of two groups, a sling or no sling group. Patients in the sling group will wear a sling for three weeks after their surgery while the no sling group will only wear a sling three days after their surgery. Patients will follow their doctors normal follow up visit schedule after surgery, with visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years.
详细描述
The purpose of this study is to determine whether or not a sling is necessary after the nerve block has worn off postoperatively for patients undergoing reverse total shoulder arthroplasty. Patients who are scheduled for a reverse total shoulder with the participating investigators will be approached for potential participation in the study.
Before the surgery, subjects will be randomly assigned to either the Sling (control) group or the No-Sling (investigational) group. The Sling, or control, group will wear a sling through 3 weeks postoperatively. The No Sling (investigational) group, will wear a sling either through 3 days postoperatively.
Following surgery, patients will be followed at their standard of care visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after their surgical date. The investigators will collect data from these standard of care visits including PROs (including but not limited to ASES and SANE), Adverse events data, and physical exam data including range of motion. Patients will be followed through their two-year visit and then taken off study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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 primary reverse shoulder arthroplasty procedure
- •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 indications for primary reverse shoulder arthroplasty for the following diagnosis
- •Rotator cuff arthropathy
- •Glenohumeral arthritis
- •Patient is between 18-100 years old
- •Patient is English speaking
排除标准
- •A history of ipsilateral shoulder arthroplasty
- •A history of shoulder septic arthritis
- •A history of a 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
研究组 & 干预措施
Sling
Participants in the sling group will wear a sling according to current standard of care: 3 weeks postoperatively (2 weeks all the time, 3rd week at night and while in the community)
No Sling
Participants in the no sling group will only wear a sling for three days postoperatively
干预措施: Time of Sling Use (Other)
结局指标
主要结局
Number of participants who develop any kind of postoperative complication
时间窗: 6 months primary, Up to the first 2 years following surgery
Incidence of postoperative complications
次要结局
- American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score(6 months primary, Up to the first 2 years following surgery)
- Single Assessment Numeric Evaluation (SANE) score(6 months primary, Up to the first 2 years following surgery)