Postoperative Deltoid EMG Activity and Function in Patients After Reverse Total Shoulder Arthroplasty: A Comparison of Standard Implantation Technique and Lateralization
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Delta Muscle activity (especially posterior Delta part)
研究概览
简要总结
Reverse total shoulder arthroplasty (RTSA) is a well-established method to treat patients with irreparable rotator cuff tears and glenohumeral osteoarthritis. The biomechanical principle implies a medialization and distalization of the center of rotation (COR). Deficiencies in internal and external rotation constitute frequently encountered functional problems. Some studies showed reduced activation of the posterior deltoid in EMG measurements, which may explain the inability to compensate these movements. Lateralized prosthetic designs demonstrated increased external rotation through an alteration of the deltoid's lever arm.
The aim of the study is to investigate the impact of lateralization on functional outcome and deltoid EMG activity in comparison to a standard implantation technique.
详细描述
Introduction Reverse total shoulder arthroplasty (RTSA) is a well-established method to treat patients with irreparable rotator cuff tears and glenohumeral osteoarthritis. The biomechanical principle is a medialization and distalization of the center of rotation (COR) to provide a compensatory role for the insufficient rotator cuff. Deficiencies in internal and external shoulder rotation constitute frequently seen functional problems. Some studies showed reduced activation of the posterior deltoid in EMG measurements, which may explain the inability to compensate these movements. Lateralized prosthetic designs implants demonstrated increased external rotation force through an alteration of the deltoid's lever arm.
Material and Methods This study will be conducted as a monocentric randomized, prospective trial. Approximately 130 patients, scheduled for reversed total shoulder arthroplasty (RSA), will be enrolled. The patients will be divided into two groups depending on receiving RSA or a lateralized implant via randomization. Preoperatively and at 4 follow-up visits, a surface EMG (sEMG) of the deltoid muscle will be conducted and clinical scores (Constant-Murley Score and Quick DASH questionnaire) will be assessed. As patient related outcome measures, p-ASES-S and SVV will be evaluated. Pre- and postoperative x-rays and CT scans will be conducted for preoperative planning and measurement of achieved lateralization. Clinical and radiological complications will be routinely documented. Group comparisons and correlations will be performed to compare both groups pre- and postoperatively. The study's duration is scheduled for 2 years.
Aim of the Study The aim of the study is to evaluate a possible difference in function and EMG activity between the two patient groups. Especially a different increase in external rotation range of motion and strength shall be investigated. Furthermore a possible connection between preoperative deltoid muscle activity and postoperative outcome shall be pointed out. Lastly, the impact of lateralization on functional outcome, shall be evaluated compared to the standard implantation technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male/female, 60-85y
- •diagnosis of Cuff tear arthropathy (CTA)
- •irreparable rotator cuff tear
- •severe osteoarthritis (OA)
- •primary RSA
- •verified rotator cuff tear in preoperative MRI
- •absence of severe cognitive impairment
排除标准
- •previous muscle transfer
- •revision surgery
- •highly dysplastic glenoid
- •axillary nerve palsy
- •upper limb radiculopathy
- •cervical myelopathy
- •degenerative muscular disease,
- •previous proximal humeral fracture
- •revision arthroplasty
- •rheumatoid arthritis
研究组 & 干预措施
Standard Implantation Group
Subjects treated with a standard glenoid component of the used reverse total shoulder prosthesis
干预措施: Standard implantation technique (Device)
Lateralized Implantation Group
Subjects treated with a lateralized glenoid component of the used reverse total shoulder prosthesis
干预措施: Lateralization of glenoid component (Device)
结局指标
主要结局
Delta Muscle activity (especially posterior Delta part)
时间窗: preoperative
The ratio between peak torque and EMG root mean square is measured
Delta Muscle activity (especially posterior Delta part)
时间窗: 6 weeks postoperative
The ratio between peak torque and EMG root mean square is measured
Delta Muscle activity (especially posterior Delta part)
时间窗: 3 months postoperative
The ratio between peak torque and EMG root mean square is measured
Delta Muscle activity (especially posterior Delta part)
时间窗: 6 months postoperative
The ratio between peak torque and EMG root mean square is measured
Delta Muscle activity (especially posterior Delta part)
时间窗: 1 year postoperative
The ratio between peak torque and EMG root mean square is measured
次要结局
- Range of movement (forward flexion, abduction, external rotation, extension)(preoperative)
- Range of movement (forward flexion, abduction, external rotation, extension)(6 weeks postoperative)
- Range of movement (forward flexion, abduction, external rotation, extension)(3 months postoperative)
- Range of movement (forward flexion, abduction, external rotation, extension)(6 months postoperative)
- Range of movement (forward flexion, abduction, external rotation, extension)(1 year postoperative)
- Objective and subjective outcome scores / Quality of life scores(preoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative, 12 months postoperative)
- Difference in lateralization between preoperative 3D CT-based planning and postoperative CT-based implant position(Preoperative and 1 year postoperative)
- Humeral Length (Millimeters) Measured on Standardized Radiographs(preoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative, 12 months postoperative)