Humeral Fracture Clinical Trial
— DELTOSUPEXOfficial title:
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | June 30, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Chu Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Constant Murley Score | 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 | 12 months | |
Secondary | Quick dash score | 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 | 3, 6 and 12 months | |
Secondary | SF12 score | 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 | 3, 6 and 12 months | |
Secondary | Alder score | Assessment of external rotation of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score | 3, 6 and 12 months | |
Secondary | The Simple Shoulder Test (SST) | 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 | 3, 6 and 12 months | |
Secondary | WOOS (The Western Ontario Osteosarthritis ) | 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 | 3, 6 and 12 months | |
Secondary | intensity of pain | 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) | pre op, 3, 6 and 12 months | |
Secondary | Radiologic evaluation | Radiologic evaluation | pre op, 3, 6 and 12 months | |
Secondary | Complications | list of the complications | pre op, 3, 6 and 12 months |
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