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| Name | Class |
|---|---|
| Tampere University Hospital | OTHER |
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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. )
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Non-Operative treatment | No Intervention | Rehabilitation with standardized physiotherapy guideline and self exercise protocol |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Ville Mattila, Professor | Professor in orthopedics and traumatology, Tampere University Chief of musculoskeletal department, Tampere University Hospital Visiting professor, Karolinska Institute, Stockholm | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital, Division of Orthopaedics | Aarhus | Denmark | ||||
| Tampere University Hospital, Division of Orthopaedics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30700485 | Background | 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. |
| Label | URL |
|---|---|
| Trial website for patients, their relatives and health workers | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 26, 2025 | Dec 26, 2025 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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Randomized controlled single-blinded trial
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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.
|
| 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. |
| 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 |
| Tampere |
| Finland |
| Oslo University Hospital, Division of Orthopaedics | Oslo | Norway |