The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly

University of Oslo (UIO)

Status: Active, not recruiting

Conditions: Proximal Humeral Fracture

Treatments: Procedure: Operative treatment with Reversed Total Shoulder Prosthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT03531463

2018/476-D

Details and patient eligibility

About

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. )

Full description

Single-blinded, multi-center, multi-national (Finland, Sweden, Denmark, Norway) Primary outcome in this study is QuickDASH (The short form of Disabilities of the arm, shoulder and hand) score measured at two years.

Secondary outcomes are QuickDASH at/after one, two (short term) and five years (medium term), general visual analog scale (VAS) for pain, Oxford shoulder score (OSS), Constant-score (CS), number of re-operations and complications. Quality of life is assessed with 15-D. Cost-effectiveness analysis will be performed after completion of the trial.

In addition to 2 years main outcome (short term) follow-up will continue to 5 years (medium term) and 10 years (long term). The power calculation is based on 2 years.

Enrollment: 154 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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154 participants in 2 patient groups

Operative treatment

Active Comparator group

Description:

Operative treatment of the displaced proximal humeral fracture with a reversed total shoulder prothesis (Delta prosthesis) using a stadardized deltopectoral approach, bone block grafting and thread cerclages of the tubercles. Rehabilitation with standardized physiotherapy guideline and self exercise protocol

Treatment:

Procedure: Operative treatment with Reversed Total Shoulder Prosthesis

Non-Operative treatment

No Intervention group

Description:

Rehabilitation with standardized physiotherapy guideline and self exercise protocol