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The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly (DeltaCon)

Primary Purpose

Proximal Humeral Fracture

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Operative treatment with Reversed Total Shoulder Prosthesis
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proximal Humeral Fracture focused on measuring Displaced, Non-Operative treatment, Reversed Total Shoulder Prosthesis

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital, Division of OrthopaedicsRecruiting
  • Tampere University Hospital, Division of OrthopaedicsRecruiting
  • Oslo University Hospital, Division of OrthopaedicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Operative treatment

Non-Operative treatment

Arm Description

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

Rehabilitation with standardized physiotherapy guideline and self exercise protocol

Outcomes

Primary Outcome Measures

Quick-DASH
The short form of Disabilities of the arm, shoulder and hand

Secondary Outcome Measures

Oxford Shoulder Score
Shoulder specific patient self-assesment
15 D Quality of Life
15 Questions 5 levels Generic Score (Harri Sintonen)
Constant score
Functional outcome for the shoulder
VAS pain
General visual analog scale (VAS) for pain
Radiographic + CT
Plain radiographs and CT of injured shoulder
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

Full Information

First Posted
April 27, 2018
Last Updated
March 26, 2023
Sponsor
Oslo University Hospital
Collaborators
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03531463
Brief Title
The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly
Acronym
DeltaCon
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Tampere University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Humeral Fracture
Keywords
Displaced, Non-Operative treatment, Reversed Total Shoulder Prosthesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled semiblinded trial
Masking
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.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Operative treatment
Arm Type
Active Comparator
Arm Description
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
Arm Title
Non-Operative treatment
Arm Type
No Intervention
Arm Description
Rehabilitation with standardized physiotherapy guideline and self exercise protocol
Intervention Type
Procedure
Intervention Name(s)
Operative treatment with Reversed Total Shoulder Prosthesis
Intervention Description
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
Primary Outcome Measure Information:
Title
Quick-DASH
Description
The short form of Disabilities of the arm, shoulder and hand
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Oxford Shoulder Score
Description
Shoulder specific patient self-assesment
Time Frame
2 years
Title
15 D Quality of Life
Description
15 Questions 5 levels Generic Score (Harri Sintonen)
Time Frame
2 years
Title
Constant score
Description
Functional outcome for the shoulder
Time Frame
2 years
Title
VAS pain
Description
General visual analog scale (VAS) for pain
Time Frame
2 years
Title
Radiographic + CT
Description
Plain radiographs and CT of injured shoulder
Time Frame
2 years
Title
Patient involvement
Description
The aim of the interviews will be to move towards patient-centered medicine by taking into account the goals, preferences and values of patients
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antti Launonen, MD, PhD
Phone
00358405508210
Email
antti.launonen@pshp.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Tore Fjalestad, MD, PhD
Phone
004797013389
Email
torfja@online.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ville Mattila, Professor
Organizational Affiliation
Professor in orthopedics and traumatology, Tampere University Chief of musculoskeletal department, Tampere University Hospital Visiting professor, Karolinska Institute, Stockholm
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital, Division of Orthopaedics
City
Aarhus
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theis M Thillemann, MD. PhD.
Email
theithil@rm.dk
Facility Name
Tampere University Hospital, Division of Orthopaedics
City
Tampere
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antti Launonen, MD, PhD
Email
antti.launonen@pshp.fi
First Name & Middle Initial & Last Name & Degree
Bakir Sumrein, MD.PhD
Facility Name
Oslo University Hospital, Division of Orthopaedics
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tore Fjalestad, MD, PhD
Phone
0047 22118080
Email
tofjal@ous-hf.no
First Name & Middle Initial & Last Name & Degree
Tore Fjalestad, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
30700485
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.
Results Reference
background
Links:
URL
https://oslo-universitetssykehus.no/avdelinger/ortopedisk-klinikk/ortopedisk-avdeling-ulleval/brudd-i-ovre-del-av-overarmsbeinet-proksimale-humerus-den-nordiske-deltacon-studien
Description
Trial website for patients, their relatives and health workers

Learn more about this trial

The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly

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