The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly (DeltaCon)

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

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. )

Study Overview

• Status: Active, not recruiting
• Conditions: Proximal Humeral Fracture
• Intervention / Treatment: Procedure: Operative treatment with Reversed Total Shoulder Prosthesis

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Aarhus University Hospital, Division of Orthopaedics
• Finland
  • Tampere, Finland
    • Tampere University Hospital, Division of Orthopaedics
• Norway
  • Oslo, Norway
    • Oslo University Hospital, Division of Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: 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
No Intervention: Non-Operative treatment; Rehabilitation with standardized physiotherapy guideline and self exercise protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick-DASH	The short form of Disabilities of the arm, shoulder and hand	From enrollment to 5 years follow-up. Scale 1-4 points (Total point x answers given) x25. Lowest point best

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Oxford Shoulder Score	Shoulder specific patient self-assesment	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)	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	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	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	From enrollemnt to 5 years follow-up for plain radiographs. CT at enrollement and at 2 years.

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Tampere University Hospital
• Investigators: Study Chair: Ville Mattila, Professor, Professor in orthopedics and traumatology, Tampere University Chief of musculoskeletal department, Tampere University Hospital Visiting professor, Karolinska Institute, Stockholm

Publications and helpful links

General Publications

• Launonen AP, Fjalestad T, Laitinen MK, Lahdeoja T, Ekholm C, Wagle T, Mattila VM; NITEP-group. Nordic Innovative Trials to Evaluate osteoPorotic Fractures (NITEP) Collaboration: The Nordic DeltaCon Trial protocol-non-operative treatment versus reversed total shoulder arthroplasty in patients 65 years of age and older with a displaced proximal humerus fracture: a prospective, randomised controlled trial. BMJ Open. 2019 Jan 29;9(1):e024916. doi: 10.1136/bmjopen-2018-024916.

Helpful Links

• Trial website for patients, their relatives and health workers

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): December 10, 2023
• Study Completion (Estimated): December 10, 2028

Study Registration Dates

• First Submitted: April 27, 2018
• First Submitted That Met QC Criteria: May 18, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Estimated): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Displaced; Non-Operative treatment; Reversed Total Shoulder Prosthesis
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Fractures, Bone; Shoulder Fractures
• Other Study ID Numbers: 2018/476-D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No