Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03531463
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03531463
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
Tampere University Hospital
Information provided by (Responsible Party):
Tore Fjalestad, 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. )

Condition or disease Intervention/treatment Phase
Proximal Humeral Fracture Procedure: Operative treatment with Reversed Total Shoulder Prosthesis Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled semiblinded trial
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.
Primary Purpose: Treatment
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
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Operative treatment

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

Procedure: Operative 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

No Intervention: Non-Operative treatment
Rehabilitation with standardized physiotherapy guideline and self exercise protocol



Primary Outcome Measures :
  1. Quick-DASH [ Time Frame: 2 years ]
    The short form of Disabilities of the arm, shoulder and hand


Secondary Outcome Measures :
  1. Oxford Shoulder Score [ Time Frame: 2 years ]
    Shoulder specific patient self-assesment

  2. 15 D Quality of Life [ Time Frame: 2 years ]
    15 Questions 5 levels Generic Score (Harri Sintonen)

  3. Constant score [ Time Frame: 2 years ]
    Functional outcome for the shoulder

  4. VAS pain [ Time Frame: 2 years ]
    General visual analog scale (VAS) for pain

  5. Radiographic + CT [ Time Frame: 2 years ]
    Plain radiographs and CT of injured shoulder

  6. Patient involvement [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531463


Contacts
Layout table for location contacts
Contact: Antti Launonen, MD, PhD 00358405508210 antti.launonen@pshp.fi
Contact: Tore Fjalestad, MD, PhD 004797013389 torfja@online.no

Locations
Layout table for location information
Finland
Tampere University Hospital, Division of Orthopaedics Not yet recruiting
Tampere, Finland
Contact: Antti Launonen, MD, PhD       antti.launonen@pshp.fi   
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Tore Fjalestad, MD, PhD    0047 22118080    tofjal@ous-hf.no   
Principal Investigator: Tore Fjalestad, MD, PhD         
Sponsors and Collaborators
Oslo University Hospital
Tampere University Hospital
Investigators
Layout table for investigator information
Study Chair: Ville Mattila, Professor Professor in orthopedics and traumatology, Tampere University Chief of musculoskeletal department, Tampere University Hospital Visiting professor, Karolinska Institute, Stockholm

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Tore Fjalestad, Principal investigator Tore Fjalestad, MD. Ph.D. Consultant Orthopaedic Surgeon, Mail: torfja@online.no / tofjal@ous-hf.no , Ph:+4797013389, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03531463     History of Changes
Other Study ID Numbers: 2018/476-D
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tore Fjalestad, Oslo University Hospital:
Displaced
Non-Operative treatment
Reversed Total Shoulder Prosthesis

Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Humeral Fractures
Shoulder Fractures
Wounds and Injuries
Arm Injuries
Shoulder Injuries