Humeral Fracture, Aged Patient, Reversed Total Shoulder Arthroplasty, Surgical Approach
Conditions
Keywords
Prospective, Randomized study, Proximal humerus fracture, Surgical treatment
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.
Interventions
PROCEDUREReversed total shoulder arthroplasty
Replacement of the proximal humeral head by a reversed prosthesis through an anterior approach
PROCEDURElateral approach
Replacement of the proximal humeral head by a reversed prosthesis through a lateral approach
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
no masking
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
France
Outcome results
None listed