The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly
- Conditions
- Proximal Humeral Fracture
- Interventions
- Procedure: Operative treatment with Reversed Total Shoulder Prosthesis
- Registration Number
- NCT03531463
- Lead Sponsor
- Oslo University Hospital
- 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. )
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 154
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.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Operative treatment Operative treatment with Reversed Total Shoulder Prosthesis 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
- Primary Outcome Measures
Name Time Method Quick-DASH 2 years The short form of Disabilities of the arm, shoulder and hand
- Secondary Outcome Measures
Name Time Method Radiographic + CT 2 years Plain radiographs and CT of injured shoulder
Patient involvement 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
Oxford Shoulder Score 2 years Shoulder specific patient self-assesment
15 D Quality of Life 2 years 15 Questions 5 levels Generic Score (Harri Sintonen)
Constant score 2 years Functional outcome for the shoulder
VAS pain 2 years General visual analog scale (VAS) for pain
Trial Locations
- Locations (3)
Aarhus University Hospital, Division of Orthopaedics
🇩🇰Aarhus, Denmark
Oslo University Hospital, Division of Orthopaedics
🇳🇴Oslo, Norway
Tampere University Hospital, Division of Orthopaedics
🇫🇮Tampere, Finland