Reverse Total Shoulder Arthroplasty With or Without Partial Coracoidectomy: a Randomized Controlled Trial Evaluating Functional Internal Rotation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment of functional internal rotation, as measured by the change in the ADLIR (Activities of Daily Living requiring Internal Rotation) score
研究概览
简要总结
This project aims to conduct a randomized controlled trial comparing the functional outcomes and complications of standard reverse total shoulder arthroplasty and reverse total shoulder arthroplasty combined with partial coracoidectomy. The study will assess functional internal rotation at 12 months post-surgery, as measured by the ADLIR (Activities of Daily Living requiring Internal Rotation) score.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Adults undergoing reverse total shoulder arthroplasty (rTSA), including primary procedures or fracture repair. Indications may include arthropathy due to a rotator cuff tear, primary glenohumeral osteoarthritis with an irreparable rotator cuff tear, or post-traumatic arthritis.
排除标准
- •Patients with a history of coracoid fractures or who have previously undergone surgery involving the coracoid process.
- •Patients undergoing latissimus dorsi transfers
- •Presence of an active infection, inflammatory arthritis, or a tumor affecting the shoulder region.
- •Patients with pre-existing neuromuscular disorders affecting shoulder function
- •Patients who are unwilling or unable to participate in the trial or complete follow-up assessments
- •Patients deprived of their liberty by judicial or administrative order, in pretrial detention, or under guardianship, conservatorship, or judicial protection.
- •Pregnant women, women in labor, or breastfeeding women
- •Patients receiving psychiatric care
- •Patients not enrolled in a social security program
研究组 & 干预措施
Reverse total shoulder arthroplasty without coracoidectomy
干预措施: Reverse total shoulder arthroplasty without coracoidectomy (Procedure)
Reverse total shoulder arthroplasty with coracoidectomy
干预措施: Reverse total shoulder arthroplasty with coracoidectomy (Procedure)
结局指标
主要结局
Assessment of functional internal rotation, as measured by the change in the ADLIR (Activities of Daily Living requiring Internal Rotation) score
时间窗: 12 months after surgery
A maximum score of 100 indicates that the patient experiences no discomfort in daily life due to limited internal rotation. A minimum score of 14 indicates severe functional impairment due to limited internal rotation.
次要结局
未报告次要终点