et's Agree to Disagree on Operative versus Nonoperative treatment for proximal humeral fractures. An international multicentre prospective cohort study
- Conditions
- Proximal humeral fractures, Isolated greater tuberosity fractures
- Registration Number
- NL-OMON26848
- Lead Sponsor
- DePuy Synthes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 220
All patients (>18 years) presenting acute displaced proximal humeral fracture involving minimally the surgical neck, including isolated greater tuberosity fractures will be eligible for inclusion.
- Open fracture
- Pre-existing co-morbidities which preclude operative treatment
- Pathological fractures, associated dislocation of injured shoulder joint
- Associated ipsilateral upper extremity fractures
- Concomitant soft tissue injury or neurovascular injuries requiring operative treatment
- Delayed presentation (> 3weeks after injury)
- Treatment for re-fractures
- Cognitive impairment
- Non-Dutch, non-German or non-English speaking patients
- Patients not resident in the hospitals area and unavailable for follow-up.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quick Dash scores at 6 weeks and 12 months
- Secondary Outcome Measures
Name Time Method - The subjective shoulder value (SSV)<br>- EuroQol five dimensional questionnaire (EQ5D)<br>- Numerical Rating Scale (NRS) Pain score<br>- Return to sports and work activity<br>- Complications<br>- Revision surgery<br>- implant removal and related complications