Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02113-52 | Other Identifier | 2018-A02113-52 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| deltopectoral approach | Active Comparator | the patients are treated with deltopectoral approach surgery |
|
| lateral approach | Other | the patients are treated with a lateral approach surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reversed total shoulder arthroplasty | Procedure | Replacement of the proximal humeral head by a reversed prosthesis through an anterior approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| SF12 score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Guillaume VILLATTE | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35727196 | Derived | Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
no masking
Not provided
| lateral approach | Procedure | Replacement of the proximal humeral head by a reversed prosthesis through a lateral approach |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Radiologic evaluation | Radiologic evaluation | pre op, 3, 6 and 12 months |
| Complications | list of the complications | pre op, 3, 6 and 12 months |
| ID | Term |
|---|---|
| D006810 | Humeral Fractures |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
Not provided
Not provided