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NCT Number: NCT03531463

The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly

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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Key information

Conditions

Proximal Humeral Fracture Fractures, Bone Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Division of Orthopaedics, Aarhus, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Operative treatment with Reversed Total Shoulder Prosthesis

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

Primary outcomes

  1. Quick-DASH

    Time frame: 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

Secondary outcomes

  1. Oxford Shoulder Score

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

    Shoulder specific patient self-assesment

  2. 15 D Quality of Life

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

    15 Questions 5 levels Generic Score (Harri Sintonen)

  3. Constant score (CS)

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

    Functional outcome for the shoulder

  4. VAS pain

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

    General visual analog scale (VAS) for pain

  5. Radiographic + Computer Tomography scan (CT)

    Time frame: From enrollemnt to 5 years follow-up for plain radiographs. CT at enrollement and at 2 years.

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

  6. Patient involvement

    Time frame: 2 years

    The aim of the interviews will be to move towards patient-centered medicine by taking into account the goals, preferences and values of patients

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Tampere University Hospital

Registry information

Official study title

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

Acronym: DeltaCon

Important dates

Study start
2018
Primary completion
2023
Study completion
2028
First posted
May 21, 2018
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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