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Clinical Trials in Denmark / NCT03531463
Active, not recruiting Not applicable

The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly

NCT03531463 · tracked via the Priya Life Science Denmark tracker
Sponsor
Oslo University Hospital
Phase
Not applicable
Started
2018-10-01
Last updated
2026-01-06

Condition(s) studied

Proximal Humeral Fracture

Investigational drug(s) / intervention(s)

Operative treatment with Reversed Total Shoulder Prosthesis

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

Study 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. )

Eligibility

Sex
ALL
Min age
65 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: Low energy AO/OTA group 11-B1.1, 11-B1.2 and 11-C1.1, 11-C3.1. Both B and C type includes subgroups: Displaced \[2\], Impacted \[3\] or Non impacted \[4\] from the universal modifiers list. Exclusion Criteria: Radiographic Mal-inclination Less than; varus 30°or valgus 45° Less than 50% contact between head fragment and meta-/diaphysis Head split fractures with more than 10% of the articular surface in the main head fragment. Head split fractures (group 11-C3.2 and 11-C3.3) with more than 10% of the articular surface in the main head fragment. Dislocation or fracture-dislocation of the gleno-humeral joint Pathological fracture General * Refuse to participate * Age under 65 years of age, or over 85 years of age * Serious poly-trauma or additional surgery * Non-independent, drug/alcohol abuse or institutionalized (low co-operation) * Contra-indications for surgery * Does not understand written and spoken guidance in local languages * Previous fracture with symptomatic sequelae in either shoulder * Patients living outside the hospital's catchment area

Primary outcome measure(s)

  • Quick-DASH — From enrollment to 5 years follow-up. Scale 1-4 points (Total point x answers given) x25. Lowest point best
    The short form of Disabilities of the arm, shoulder and hand

Trial sites (3)

FacilityCityRegionStatus
Aarhus University Hospital, Division of Orthopaedics Aarhus Denmark
Tampere University Hospital, Division of Orthopaedics Tampere Finland
Oslo University Hospital, Division of Orthopaedics Oslo Norway

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Other trials for the same condition

Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years Recruiting
Comparing Outcomes of Non-surgical Versus Surgical Treatment of Shoulder Fractures With Different Shoulder Replacements Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03531463 on ClinicalTrials.gov ↗ ← All trials in Denmark