Proximal Humeral Fracture
Conditions
Keywords
Displaced, Non-Operative treatment, Reversed Total Shoulder Prosthesis
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.
Interventions
PROCEDUREOperative 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
Sponsors
Tampere University Hospital
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized controlled single-blinded trial
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quick-DASH | 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
| Measure | Time frame | Description |
|---|---|---|
| 15 D Quality of Life | 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) |
| Constant score (CS) | From enrollment to 5 years follow-up. Scale 0- 100 points. Highest best if only actual shoulder is scored.. | Functional outcome for the shoulder |
| Oxford Shoulder Score | From enrollment to 5 years follow-up. Scale 0 - 48, lowest score best. | Shoulder specific patient self-assesment |
| Radiographic + Computer Tomography scan (CT) | 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 |
| 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 |
| VAS pain | From enrollement to 5 eyars follow-up. Scale 0-15 points, best equal zero points | General visual analog scale (VAS) for pain |
Countries
Denmark, Finland, Norway
Outcome results
None listed