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ACTIVE NOT RECRUITING
NCT03531463
NA

The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly

Sponsor: Oslo University Hospital

View on ClinicalTrials.gov

Summary

The Nordic DeltaCon Trial is a prospective, single-blinded, randomized, controlled, multi-center and multi-national trial comparing reverse prosthesis and non-operative treatment in displaced proximal humerus fractures, in the elderly patients aged 65 to 85 years with displaced OTA/AO group B2 or C2 fractures (According to the new 2018 revision: AO/OTA (Orthopaedic Trauma Association) group 11-B1.1, 11-B1.2 and 11-C1.1, 11-C3.1. )

Official title: Nordic DeltaCon Trial: Non-operative Treatment Versus Reversed Total Shoulder Prosthesis in Patients Sixty Five Years of Age and Older With Displaced 3- and 4 Parts Proximal Humeral Fractures - a Prospective, Randomized Controlled Trial

Key Details

Gender

All

Age Range

65 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

154

Start Date

2018-10-01

Completion Date

2028-12-10

Last Updated

2026-01-06

Healthy Volunteers

No

Interventions

PROCEDURE

Operative treatment with Reversed Total Shoulder Prosthesis

The standardized approach is the delto-pectoral to minimize any damage of the deltoid muscle. A cemented monoblock humeral stem will be implanted. Braided polyester suture-cerclages engaging the insertion of the subscapular and infraspinatus tendons enforced by a bonegraft or a "horseshoe-graft" from the humeral head will be used

Locations (3)

Aarhus University Hospital, Division of Orthopaedics

Aarhus, Denmark

Tampere University Hospital, Division of Orthopaedics

Tampere, Finland

Oslo University Hospital, Division of Orthopaedics

Oslo, Norway