Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures

Herlev and Gentofte Hospital

Status: Enrolling

Conditions: Intra-Articular Fractures; Comminuted Fracture; Distal Humerus Fracture

Treatments: Procedure: Surgical treatment of distal humeral fracture with elbow hemiarthroplasty; Procedure: Surgical treatment of distal humeral fracture with double plating.

Study type: Interventional

Funder types: Other

Identifiers

NCT04163172

EVORI

Details and patient eligibility

About

This is a randomized control trial comparing the outcome of ORIF (open reduction and internal fixation) with EHA (elbow hemiarthroplasty) for distal humeral fractures in patients aged 50 years or above.

Full description

Intraarticular distal humeral fractures AO/OTA type C2 and C3 pose a surgical challenge despite the evolution of surgical implants and techniques. Open reduction and internal fixation (ORIF) is often preferred as the first choice of treatment, but the results are varying, and sometimes disappointing. Total elbow arthroplasty (TEA) has been widely used for fractures that are not amenable to ORIF in elderly patients, but the mechanical complications remain a challenge, especially in active patients. Elbow hemiarthroplasty (EHA) provides a modern alternative that might avoid the mechanical complications and weight bearing restrictions related to the linked articulation in semiconstrained TEA. There are no studies comparing the results of EHA to that of TEA or ORIF, but case series have reported promising results.

In this study, forty-four patients with AO/OTA type C2 or C3 fractures of distal humerus will be randomized to either ORIF or EHA. The patients will be examined after the operation and at 3 months and 1, 2, 5 and 10 years after the surgery. The main objective of this study is to investigate the best treatment option for distal humeral fractures in patients aged 50 years or above. This can be of value to future patients sustaining these complicated fractures.

Enrollment: 44 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Distal humeral fracture AO/OTA type C2 or C3 confirmed by plain radiographs with 2 perpendicular views and CT scan.
2. ASA score 1-3 and physically fit for surgery.
3. Age of 50 years or above.

Exclusion criteria

1. Patients unable to follow the rehabilitation protocol or answer the Danish questionnaires because of physical or cognitive inabilities as evaluated by the recruiting surgeon.
2. Significant elbow osteoarthritis as evaluated by the recruiting surgeon based on plain radiographs and CT scan.
3. Fractures that are older than 6 weeks.
4. Other associated elbow fractures.
5. Pathological fractures or relevant elbow pathology.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Elbow hemiarthroplasty

Active Comparator group

Description:

The Latitude anatomical hemiarthroplasty (WRIGHT -Memphis, Tennessee) for distal humeral fractures.

Treatment:

Procedure: Surgical treatment of distal humeral fracture with elbow hemiarthroplasty

Open reduction and internal fixation

Active Comparator group

Description:

Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States) for distal humeral fractures.

Treatment:

Procedure: Surgical treatment of distal humeral fracture with double plating.