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Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture

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合作者:
信息的提供 (责任方):
October 1, 2018
October 3, 2018
October 3, 2018
November 2, 2018
November 30, 2020   (主要结果测量的最终数据收集日期)
Constant Murley Score[ Time Frame: 12 months ]
Constant Murley Score it a clinical method of functional assessment of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score

与当前相同
  • Quick dash score[ Time Frame: 3, 6 and 12 months ]
    the Quick Dash score is a functional assessment of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score
  • SF12 score[ Time Frame: 3, 6 and 12 months ]
    The SF12 score is a quality of life assessment. The score varies between 0 and 100, more the value is better brought up is the score
  • Alder score[ Time Frame: 3, 6 and 12 months ]
    Assessment of external rotation of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score
  • The Simple Shoulder Test (SST)[ Time Frame: 3, 6 and 12 months ]
    The Simple Shoulder Test is functional assessment of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score
  • WOOS (The Western Ontario Osteosarthritis )[ Time Frame: 3, 6 and 12 months ]
    The Western Ontario Osteosarthritis of the shoulder index is a quality of life measurement tool for osteoarthritis of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score
  • intensity of pain[ Time Frame: pre op, 3, 6 and 12 months ]
    THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10)
  • Radiologic evaluation[ Time Frame: pre op, 3, 6 and 12 months ]
    Radiologic evaluation
  • Complications[ Time Frame: pre op, 3, 6 and 12 months ]
    list of the complications
 
Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture
Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture

The aim of the study consists in comparing two surgical approaches (deltopectoral versus lateral deltoid splitting) in the treatment of proximal humerus fractures treated with a reversed total shoulder arthroplasty The assessment will focus on clinical (clinical scores, efficacy, safety…) and radiological results, between these two types of surgical approaches by using a prospective, randomized analysis.

The 2 main surgical approaches in total shoulder arthroplasty (TSA) are the anterior approach (deltopectoral) and the lateral one (deltoid splitting) (18). Their advantages and drawbacks have not been clearly evaluated in proximal humerus fracture treated with an arthroplasty. The goal of the study is to compare the results between patients (older than 65yo) presenting a proximal humerus fracture treated with a reversed shoulder arthroplasty performed through an anterior approach or a lateral one.
Interventional
N/A
分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:no masking
主要目的: Treatment
  • Procedure: Reversed total shoulder arthroplasty
    Replacement of the proximal humeral head by a reversed prosthesis through an anterior approach
  • Procedure: lateral approach
    Replacement of the proximal humeral head by a reversed prosthesis through a lateral approach
  • Active Comparator: deltopectoral approach
    the patients are treated with deltopectoral approach surgery
  • Other: lateral approach
    the patients are treated with a lateral approach surgery
 
Not yet recruiting
80
与当前相同
June 30, 2021
November 30, 2020   (主要结果测量的最终数据收集日期)
Inclusion Criteria: - Patient older than 65yo with a proximal humerus fracture (Neer 3-4 and 2 dislcated) - Patient registered to the national health system - Patient able to understand information about the protocol and answer to questionnaire Exclusion Criteria: - Non-displaced fracture or no need of surgical treatment. - Existing bone disease - Infection - Neurological deficit (axillary nerve) - Multi-injured patients - Patient no able to fulfill the questionnaire - Patient refuses the study
参与研究的性别: All
最小年龄:65 Years ,最大年龄:N/A  
没有
France
 
研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No
计划分享 IPD:
University Hospital, Clermont-Ferrand
Principal Investigator: Guillaume VILLATTE University Hospital, Clermont-Ferrand
October 2018

ICMJE     国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素
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