Immobilization Versus Early Range of Motion in Reverse Total Arthroplasty in Patients With Proximal Humerus Fractures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Early postoperative range of motion
研究概览
简要总结
The purpose of this study is to evaluate compare postoperative range of motion in patients who are given a sling for comfort only and allowed to start early active range of motion compared to patients who are placed in a sling for 4 weeks with passive range of motion only. Once enrolled, the patients will be randomized through computer randomization then placed in paper packets into either the immobilization group or the early range of motion group.
详细描述
Reverse shoulder arthroplasty is often used for older patients with displaced proximal humerus fractures in the older patient population. Many surgeons have historically placed patients in a sling for 4-6 weeks after surgery to prevent dislocation or tuberosity displacement. More recently though, surgeons are becoming more lenient with these restrictions as they realize it is very difficult for an elderly patient to be immobilized for 4-6 weeks. There has been one randomized control trial looking at early range of motion versus immobilization for 6 weeks after a regular reverse total shoulder arthroplasty not done for fracture which showed no difference at one year. There have not been any studies to date looking at reverse total shoulder arthroplasty for fracture to see if there is any difference in range of motion at early or later time points and also if there is an increased risk of complications.
Preoperative visit/hospitalization: The patient will be identified as meeting inclusion criteria and the study will be explained to them. Patients will be given a consent form to review with adequate time to review and decide if they wish to participate. If they choose to participate, the patient will sign consent forms witnessed by personnel not associated with the study. Patients will be randomized once consent has been obtained.
The patient will then undergo surgery. Operative data will be collected from their chart including implants used, and intraoperative complications. They will be placed in a sling if they are randomized to the sling group and given instructions on passive range of motion exercises to start postoperative day one. If they are assigned to the early motion group they will be placed in a sling for comfort after surgery but told they can remove it when they feel their pain will allow. They will also be instructed on the same passive range of motion program as the sling group. This is different from the standard of care.
Once enrolled, the patients will be randomized through computer randomization then placed in paper packets into either the immobilization group or the early range of motion group.
They will undergo their reverse total shoulder arthroplasty for fracture as they will even if they do not agree to participate in the study (normal treatment)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 60 years or older who have a displaced proximal humerus fracture
- •Meets surgical criteria for a reverse total shoulder arthroplasty
- •Receive surgical intervention within 6 weeks of initial injury
排除标准
- •Patients <60 years in age
- •Patients who cannot undergo surgery due to medical comorbidities
- •Patients who receive surgical intervention after 6 weeks from initial injury
- •Patients who have preoperative nerve damage from their fractures that would limit the ability to move the arm postoperatively
结局指标
主要结局
Early postoperative range of motion
时间窗: 2 years
the postoperative range of motion (ROM) will be compared between the 2 groups at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and two years
Postoperative Pain
时间窗: 2 years
Patients will rate their pain using the VAS pain scale survey. The visual analog scale (VAS) is a pain rating scale first used by Hayes and Patterson in 1921. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). This scale will be administered to both groups at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years. The results of these scores will be compared between the two groups at each time point.
Shoulder function
时间窗: 2 years
the postoperative shoulder function assessed by the American Shoulder and Elbow Scale (ASES). This scale includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. The survey will be administered to both groups at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years. The results of these scores will be compared between the two groups at each time point.
Postoperative complication
时间窗: 2 years
the 2 year postoperative complications will be recorded and compared between the 2 cohorts.
Tuberosity Healing on Radiographs
时间窗: 2 years
Radiographic outcomes regarding the degree of tuberosity healing will be obtained at each postoperative visit until the 2 year mark and compared between the 2 cohorts After initial imaging, patients will receive subsequent X-rays to monitor tuberosity healing, progression of fracture gap closure with bone formation, and signs of bone resorption. Healing is defined as lack of displacement with consolidation of the fracture and disappearance of previous fracture lines. Displacement will be measured in millimeters compared to position on previous xrays.
次要结局
未报告次要终点
研究者
Catherine Fedorka MD
Orthopaedic Surgeon, Assistant Professor of Orthopaedic Surgery, Assistant Program Director, Orthopaedic Surgery Residency Program
The Cooper Health System