The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly

N/AActive Not RecruitingNCT03531463

Oslo University Hospital154 enrolled

Overview

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. )

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

154

Conditions

Proximal Humeral Fracture

Interventions

Operative treatment with Reversed Total Shoulder ProsthesisPROCEDURE

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

Eligibility

Sex: ALLMin age: 65 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Quick-DASH

The short form of Disabilities of the arm, shoulder and hand

Time frame: From enrollment to 5 years follow-up. Scale 1-4 points (Total point x answers given) x25. Lowest point best

Secondary Outcomes

Oxford Shoulder Score

Shoulder specific patient self-assesment

Time frame: From enrollment to 5 years follow-up. Scale 0 - 48, lowest score best.

15 D Quality of Life

15 Questions 5 levels Generic Score (Harri Sintonen)

Time frame: From enrollemtn to 5 years follow-up. 15 questions, 5 levels, scale 0.000 - 1.000. Highest number best.

Constant score (CS)

Functional outcome for the shoulder

Time frame: From enrollment to 5 years follow-up. Scale 0- 100 points. Highest best if only actual shoulder is scored..

VAS pain

General visual analog scale (VAS) for pain

Time frame: From enrollement to 5 eyars follow-up. Scale 0-15 points, best equal zero points

Radiographic + Computer Tomography scan (CT)

Plain radiographs 2 plane (true front + scapula Y view) and CT of injured shoulder

Time frame: From enrollemnt to 5 years follow-up for plain radiographs. CT at enrollement and at 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

Time frame: 2 years

Data from ClinicalTrials.gov

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