The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2028-12-10

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. )

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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.

Conditions

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Proximal Humeral Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled single-blinded trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Physiotheraphists specialized in shoulder injuries collect all data and perform all tests / interviews of patients during FU at 3 months, 1-2-5 years. Blinded for the allocation / treatment.

Study Groups

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Operative treatment

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

Group Type ACTIVE_COMPARATOR

Operative treatment with Reversed Total Shoulder Prosthesis

Intervention Type PROCEDURE

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

Non-Operative treatment

Rehabilitation with standardized physiotherapy guideline and self exercise protocol

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

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

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Tore Fjalestad

Principal investigator Tore Fjalestad, MD. Ph.D. Consultant Orthopaedic Surgeon, Mail: [email protected] / [email protected] , Ph:+4797013389

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ville Mattila, Professor

Role: STUDY_CHAIR

Professor in orthopedics and traumatology, Tampere University Chief of musculoskeletal department, Tampere University Hospital Visiting professor, Karolinska Institute, Stockholm