Clinical Trials Directory

Trials / Unknown

UnknownNCT02944058

Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures

Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures. A RCT

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
79 (actual)
Sponsor
University Hospital, Akershus · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of the project is to compare the management of 3 and 4 part proximal humerus fractures (PHF) with an angular stable plate (Philos) with that of an intramedullary nail (Multiloc) in light of complications, radiological, economical, functional and clinical outcome.

Detailed description

Randomized controlled trial (RCT) from Akershus University Hospital in Norway. Randomization between two implants. The investigators will use deltopectoral or deltoid split as surgical access. All patients will have calcar screws and cuff sutures. When lack of bone for example after decompressing valgus compressed fractures, a bone-substitute might be used in the surgeons preference. Follow up in outpatient clinic at 6, 12, 52 and 104 weeks, but also a 5 year follow up is planned. Postoperative radiographs of both shoulders and CT of operated shoulder will be taken.

Conditions

Interventions

TypeNameDescription
PROCEDUREMultiloc nailIntervention is surgery with Multiloc nail
PROCEDUREPhilos plateIntervention is surgery with Philos plate

Timeline

Start date
2016-10-01
Primary completion
2023-10-24
Completion
2025-10-25
First posted
2016-10-25
Last updated
2023-08-15

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT02944058. Inclusion in this directory is not an endorsement.