NCT01557413.
Study name | Randomised study between intramedullary locking nails and locking plates for treatment of proximal humerus fractures (HUMERUS) Official title: Randomised study between intramedullary locking nails and locking plates for treatment of proximal humerus fractures in patients after 40‐year‐old |
Methods | Single‐centre, randomised controlled trial. Unblinded |
Participants | 80 participants, aged between 40 and 85 years, with a type III or IV "cephalotuberosity" proximal humeral fracture (classification of Neer and Duparc) |
Interventions | 1. Intramedullary nail (Multilock, Synthes) 2. Locking plate (SURFIX, Integra) |
Outcomes | Follow‐up: 1 year Primary outcome: Constant score Secondary outcomes: QuickDASH, complication (malunion, necrosis, infection) |
Starting date | Start date: February 2012 Completion date: December 2016 |
Contact information | Dr Patrick Boyer Group Hospitalier Bichat ‐ Claude Bernard 46, rue Henri‐Huchard Paris Ile de France France 75018 patrick.boyer@bch.aphp.fr |
Notes | Entry for trial (clinicaltrials.gov) on 19 January 2015, indicated that this "study is currently recruiting participants"; "Verified August 2014 by Assistance Publique ‐ Hôpitaux de Paris". Study completion date changed from November 2015 to February 2017. The estimated enrolment dropped from 144 to 84. Entry for trial (clinicaltrials.gov) on 2 March 2020 indicated that study was completed December 2016. The actual enrolment was 80. Request sent to lead author on 2 March 2020 inquiring on publication status; no response received. Conference poster of 2019, with abstract by Boyer and Dukan, was identified and initially we treated this as a separate trial but believe these belong together. Summary below: Participants: 75 patients with 3‐ and 4‐part displaced acute proximal humeral fractures, mean age 69 years Interventions: 1. Locking compression plate: Surfix Plate (Intergra); 2. Intramedullary interlocking nail: Multilock Nail (Synthes). All had early rehabilitation and 6 weeks in a sling. Outcomes: Constant score, American Shoulder and Elbow Surgeons (ASES) score, complications (non‐union, malunion, secondary displacement, avascular necrosis, impingement, hardware removal), forward flexion, abduction, VAS pain, and muscle strength. Notes: Reported in a conference abstract and poster only. Abstract presents results for follow‐up at mean 28 months (24 to 36 months) for 71 participants; poster for 75 participants at mean 34 months follow‐up. Specific searches for the authors of this trial have not identified a relevant publication. Top‐up search conducted in November 2021 identified a full trial report that reported results for 85 participants at a mean of 66 months follow‐up (Z‐TUp Boyer 2021). |