The ReShAPE trial: Reverse Shoulder Arthroplasty for treatment of Proximal humeral fractures in the Elderly
- Conditions
- Proximal Humeral FracturesInjuries and Accidents - FracturesSurgery - Surgical techniques
- Registration Number
- ACTRN12616000345482
- Lead Sponsor
- Dr Geoffrey Smith
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
3 or 4 part proximal humerus fracture according to the Neer classification
Medically fit for surgery
Patient 70 years of age or older
Presentation within 28 days after injury
Independent living (including hostel accommodation)
Isolated injury
Available for follow up for 24 months
Inability to consent (limited cognitive capacity judged by 3 or more errors on the mini-mental status examination 6 item screener or limited English proficiency)
Pre-existing injury or condition of the affected side which severely affected the movement of the shoulder (eg CVA, pre-existing shoulder pathology, previous fracture or surgery)
Pathological fracture
Other injury to the same upper limb requiring surgery
Open fracture
Fracture-dislocation or head splitting fracture
Glenoid fracture
Axillary nerve palsy
Gross fracture displacement – no bony contact between humeral shaft and articular segment
Medical condition precluding anaesthetic
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ASES (American Shoulder and Elbow Society) Standardised Shoulder Assessment score patient self-report section. <br>This scoring system consists of two dimensions: pain and activities of daily living, which are both equally weighted giving a total score out of 100. It has been show to be reliable, valid and responsive across a number of shoulder pathologies <br>[ASES score will be measured at 3 months 6 months 1, 2, 5 and 10 years. ]
- Secondary Outcome Measures
Name Time Method