The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly

NCT03531463 | Active Not Recruiting DMC

• 1 other identifier: 2018/476-D
• Study Type: interventional
• Target: 154
• Locations: 3 countries
• Sites: 3

Brief Summary

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. )

Conditions

Proximal Humeral Fracture

Keywords

Displaced; Non-Operative treatment; Reversed Total Shoulder Prosthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Oxford Shoulder Score

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

• 15 D Quality of Life

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

• Constant score (CS)

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

• VAS pain

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

• Radiographic + Computer Tomography scan (CT)

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

Study Arms (2)

Operative treatment

ACTIVE COMPARATOR

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

Non-Operative treatment

NO INTERVENTION

Rehabilitation with standardized physiotherapy guideline and self exercise protocol

Interventions

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

Operative treatment

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Tampere University Hospital: collaborator

Study Sites (3)

Aarhus University Hospital, Division of Orthopaedics

Aarhus, Denmark

Location

Tampere University Hospital, Division of Orthopaedics

Tampere, Finland

Location

Oslo University Hospital, Division of Orthopaedics

Oslo, Norway

Location

Related Publications (1)

• 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.

  PMID: 30700485 BACKGROUND

Related Links

• Trial website for patients, their relatives and health workers

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Study Officials

• Ville Mattila, Professor

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator Tore Fjalestad, MD. Ph.D. Consultant Orthopaedic Surgeon, Mail: torfja@online.no / tofjal@ous-hf.no , Ph:+4797013389

Model Details: Randomized controlled single-blinded trial

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 21, 2018
• Study Start: October 1, 2018
• Primary Completion: December 10, 2023
• Study Completion (Estimated): December 10, 2028
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

DK (1); NO (1); FI (1)