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. 2022 Jun 21;2022(6):CD000434. doi: 10.1002/14651858.CD000434.pub5

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).