Clinical trial NCT03531463: The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Proximal Humeral Fracture
Keywords: Displaced
Non-Operative treatment
Reversed Total Shoulder Prosthesis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
First posted: 2018-05-21
Enrollment: 154
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled single-blinded trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quick-DASH
timeFrame: 2 years
Secondary outcomes:
measure: Oxford Shoulder Score
timeFrame: 2 years
measure: 15 D Quality of Life
timeFrame: 2 years
measure: Constant score
timeFrame: 2 years
measure: VAS pain
timeFrame: 2 years
measure: Radiographic + CT
timeFrame: 2 years
measure: Patient involvement
timeFrame: 2 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Division of Orthopaedics
city: Tampere
country: Finland
facility: Tampere University Hospital, Division of Orthopaedics
city: Oslo
country: Norway
facility: Oslo University Hospital, Division of Orthopaedics
Study officials:
affiliation: Professor in orthopedics and traumatology, Tampere University Chief of musculoskeletal department, Tampere University Hospital Visiting professor, Karolinska Institute, Stockholm
name: Ville Mattila, Professor
role: STUDY_CHAIR
References:
citation: 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.