The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly

Proximal Humeral Fracture Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03531463
• Other study ID #: 2018/476-D
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: March 1, 2028

Study information

• Verified date: December 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. )

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 154
• Est. completion date: March 1, 2028
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humeral Fracture
• Shoulder Fractures

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Division of Orthopaedics	Aarhus
Finland	Tampere University Hospital, Division of Orthopaedics	Tampere
Norway	Oslo University Hospital, Division of Orthopaedics	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Tampere University Hospital

Countries where clinical trial is conducted

Denmark,  Finland,  Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quick-DASH	The short form of Disabilities of the arm, shoulder and hand	2 years
Secondary	Oxford Shoulder Score	Shoulder specific patient self-assesment	2 years
Secondary	15 D Quality of Life	15 Questions 5 levels Generic Score (Harri Sintonen)	2 years
Secondary	Constant score	Functional outcome for the shoulder	2 years
Secondary	VAS pain	General visual analog scale (VAS) for pain	2 years
Secondary	Radiographic + CT	Plain radiographs and CT of injured shoulder	2 years
Secondary	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

External Links

•   Trial website for patients, their relatives and health workers