The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly

Study Overview
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Brief Summary
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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. )

Detailed Description
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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.

Official Title
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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

Conditions
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Proximal Humeral Fracture

Intervention / Treatment
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* Procedure: Operative treatment with Reversed Total Shoulder Prosthesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled single-blinded trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Operative treatment<br>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 | Procedure: Operative treatment with Reversed Total Shoulder Prosthesis<br>* 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<br>|
| No Intervention: Non-Operative treatment<br>Rehabilitation with standardized physiotherapy guideline and self exercise protocol | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick-DASH | The short form of Disabilities of the arm, shoulder and hand | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Shoulder Score | Shoulder specific patient self-assesment | 2 years | 
| 15 D Quality of Life | 15 Questions 5 levels Generic Score (Harri Sintonen) | 2 years | 
| Constant score | Functional outcome for the shoulder | 2 years | 
| VAS pain | General visual analog scale (VAS) for pain | 2 years | 
| Radiographic + CT | Plain radiographs and CT of injured shoulder | 2 years | 
| Patient involvement | The aim of the interviews will be to move towards patient-centered medicine by taking into account the goals, preferences and values of patients | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Displaced, Non-Operative treatment, Reversed Total Shoulder Prosthesis