Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture
- Conditions
- Humeral FractureAged PatientReversed Total Shoulder ArthroplastySurgical Approach
- Interventions
- Procedure: Reversed total shoulder arthroplastyProcedure: lateral approach
- Registration Number
- NCT03694457
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description deltopectoral approach Reversed total shoulder arthroplasty the patients are treated with deltopectoral approach surgery lateral approach lateral approach the patients are treated with a lateral approach surgery
- Primary Outcome Measures
Name Time Method Constant Murley Score 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
- Secondary Outcome Measures
Name Time Method Quick dash score 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 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 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) 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 ) 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 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 pre op, 3, 6 and 12 months Radiologic evaluation
Complications pre op, 3, 6 and 12 months list of the complications
Trial Locations
- Locations (1)
Chu Clermont-Ferrand
🇫🇷Clermont-Ferrand, France