Howard 2018.
| Study name | Open reduction internal fixation vs nonoperative management in proximal humerus fractures: a prospective, randomized controlled trial protocol |
| Methods | Randomised, single‐centre, single‐blind (outcome assessors), clinical trial |
| Participants | 30 participants (actual) aged > 60 years with acute 2‐ or 3‐part proximal humeral fractures, or 4‐part fractures that are deemed amenable to surgical fixation Inclusion criteria: displaced 2‐, 3‐ or 4‐part proximal humeral fractures (Neer classification), > 60 years of age, low‐energy mechanism of injury, acute fracture (< 3 weeks) |
| Interventions | 1. Open reduction and internal fixation (ORIF) with locked plate 2. Non‐operative treatment: sling immobilisation for a period of 6 weeks |
| Outcomes | Follow‐up: 3, 6, 12 and 24 months Primary outcome: Constant score Secondary outcomes: American Shoulder and Elbow Surgeons Standardized Shoulder Assessment, Short Form‐36, complication rates, reoperation rates, radiographic time to union, radiographic malunion, hardware position and evidence of avascular necrosis or post‐traumatic osteoarthritis |
| Starting date | Start date: September 2015 Estimated end date: August 2020 |
| Contact information | Peter Lapner The Ottawa Hospital Ottawa Ontario Canada, K1H8L6 Telephone: 613‐737‐8899 Ext. 78377 Email: plapner@toh.on.ca |
| Notes | Target no. of participants was 160 Discrepancies between the published protocol and the trial registration document:
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