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Recruiting NCT04163172

Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures

No phase Interventional Distal Humerus Fracture Comminuted Fracture Intra-Articular Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgical treatment of distal humeral fracture with elbow hemiarthroplasty, Surgical treatment of distal humeral fracture with double plating..
Who it may be relevant to
Registry conditions: Distal Humerus Fracture, Comminuted Fracture, Intra-Articular Fractures. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Elbow Hemiarthroplasty Versus Open Reduction and Internal Fixation for AO/OTA Type C2 and C3 Fractures of Distal Humerus in Patients Aged 50 Years or Above; a Randomized Controlled Trial

Overview

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.

Detailed 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.

Interventions

  • Procedure Surgical treatment of distal humeral fracture with elbow hemiarthroplasty
    Latitude anatomical elbow hemiarthroplasty (WRIGHT -Memphis, Tennessee)
  • Procedure Surgical treatment of distal humeral fracture with double plating.
    Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States)

Primary outcome measures

  • Oxford Elbow Score (OES) [Time frame: 2 years after surgery.]
Secondary outcome measures (4)
  • Mayo Elbow Performance Score (MEPS) [Time frame: 3 months after surgery and 1, 2, 5, and 10 years after surgery.]
  • Pain severity score (VAS) [Time frame: 3 months after surgery and 1, 2, 5, and 10 years after surgery.]
  • Range of motion [Time frame: 3 months after surgery and 1, 2, 5, and 10 years after surgery.]
  • Patients satisfaction [Time frame: 3 months after surgery and 1, 2, 5, and 10 years after surgery.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Herlev and Gentofte University Hospital — Copenhagen

Publications

  • Al-Hamdani A, Rasmussen JV, Holtz K, Olsen BS. Elbow hemiarthroplasty versus open reduction and internal fixation for AO/OTA type 13 C2 and C3 fractures of distal humerus in patients aged 50 years or above: a randomized controlled trial. Trials. 2020 Jun 8;21(1):497. doi: 10.1186/s13063-020-04418-8. PMID 32513252

Identifiers

NCT: NCT04163172 · EVORI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗