Retrovertion Assesment and Study of the Subscapularis Function in Elderly Patients With Reverse Total Shoulder Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- INTERNAL ROTATION
研究概览
简要总结
Determine the optimal degree of retroversion (0-30º) to obtain the best rotational mobility, both internal and external, of the shoulder after implanting a reversed sghoulder arthroplasty (Comprehensive system), and analyze the functional and radiologic results based on humeral retroversion.
详细描述
Methodology: Open randomized controlled clinical trial. It will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital from January 2019 to June 2021. The estimated sample will be 30 patients per group with diagnosis of massive rotator cuff rupture, rotator cuff arthropaty and primary osteoarthritis with cuff injury, with Walch's type B2 glena or in patients older than 80 years. A global study will be carried out preoperatively and postoperatively with radiographs, computerized tomography, magnetic resonance, and a biomechanical study.
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 (Participant)
盲法说明
Open randomized controlled clinical trial.
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
- •men and women over 60 with the diagnosis rotator cuff massive break (Hamada 2 or more), arthrosis secondary to ruptures of the rotator cuff and primary osteoarthritis with lesion of the cuff, with full Walch B2 type or in patients older than 80 years. Inclusion criteria
- •Good functionality of the deltoid muscle.
- •Presence of minor round (Hornblower test - no muscle atrophy in nuclear magnetic resonance)
- •Accept informed consent
排除标准
- •- Review of hemiarthroplasty or anatomical proesis of the affected shoulder.
- •Fracture of shoulder in the upper extremity to intervene.
- •Central neurological diseases
- •Advanced cognitive impairment
- •Brachial plexus injuries
- •Local or systemic infection.
- •Oncological disease
- •Treatment with immunosuppressants.
研究组 & 干预措施
humeral retroversion 30º
will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital
humeral retroversion 0º
will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital
干预措施: humeral retroversion (Procedure)
结局指标
主要结局
INTERNAL ROTATION
时间窗: 2 YEARS
AT THE SIDE (HAND TO the BACK from CONSTANT TEST)
次要结局
- abduction(2 years)
- FORWARD ELEVATION(2 YEARS)
- center of rotation(2 years)
- EXTERNAL ROTATION(2 YEARS)
- ASES test(2 years)
- Glenoid inclination angle(2 years)
- glenoid retroversion angle(2 years)
- lateralizaiton offset(2 years)
- Simple shoulder test(2 years)
- Constant test(2 years)
研究者
Josep Maria Mora Guix
Chief of Shoulder Unit
Consorci Sanitari de Terrassa