Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures

Last updated: October 5, 2023
Sponsor: Herlev and Gentofte Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bone Fractures

Treatment

Surgical treatment of distal humeral fracture with elbow hemiarthroplasty

Surgical treatment of distal humeral fracture with double plating.

Clinical Study ID

NCT04163172
EVORI
  • Ages > 50
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 44
Treatment Group(s): 2
Primary Treatment: Surgical treatment of distal humeral fracture with elbow hemiarthroplasty
Phase:
Study Start date:
February 01, 2020
Estimated Completion Date:
December 31, 2032

Study 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.

Connect with a study center

  • Herlev and Gentofte University Hospital

    Copenhagen,
    Denmark

    Active - Recruiting

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