Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04163172

Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev and Gentofte University Hospital

Copenhagen, Denmark

Location status: Recruiting

Location contact

Ali Al-Hamdani, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgical treatment of distal humeral fracture with elbow hemiarthroplasty

Procedure

Latitude anatomical elbow hemiarthroplasty (WRIGHT -Memphis, Tennessee)

Surgical treatment of distal humeral fracture with double plating.

Procedure

Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States)

Primary outcomes

  1. Oxford Elbow Score (OES)

    Time frame: 2 years after surgery.

    The OES is a 12-item patient-administrated questionnaire that measures the quality of life in patients with elbow disorder. There are three unidimensional domains: Elbow function, pain, and social-psychological status. Each question is answered on a 5-point scale with each question contributing equally to the total score.Thus, the total score ranges from 12-60, with 60 being the worst. For ease of presentation the score is converted to a scale from 0-48 with 48 being the best. The outcome can be interpreted based on a 48-point scale: 0 - 19 - poor; 20-29 - fair; 30-39 - good; and 40-48 - excellent. The Danish version which will be used in this study, has been translated and cultural adapted according to the guidelines by Guillemin, Bombardier and Beaton.

Secondary outcomes

  1. Mayo Elbow Performance Score (MEPS)

    Time frame: 3 months after surgery and 1, 2, 5, and 10 years after surgery.

    The MEPS is a surgeon-administrated instrument that evaluates the outcome after elbow surgery. There are four domains including: Pain (0-45 points), range of motion (0-20 points), stability (0-10 points) and difficulties in daily activities (0-25 points).The outcome can be interpreted based on a 100 points scale: 0 - 60 - poor; 60-74 - fair; 75-89 - good; and 90-100 - excellent.

  2. Pain severity score (VAS)

    Time frame: 3 months after surgery and 1, 2, 5, and 10 years after surgery.

    Pain is answered on a visual analogue scale (VAS) ranging from 0 to 10, with 10 being the worst and 0 represents a pain free elbow.

  3. Range of motion

    Time frame: 3 months after surgery and 1, 2, 5, and 10 years after surgery.

    Measuring the flexion/extension and supination/pronation arcs in degrees.

  4. Patients satisfaction

    Time frame: 3 months after surgery and 1, 2, 5, and 10 years after surgery.

    Patients satisfaction of the treatment will be recorded using 5-items score with 1 being the worst and 5 represents a very satisfied patient.

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Al-Hamdani, MD

CONTACT

[email protected]

004538673276

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2026
Study completion
2032
First posted
Nov 14, 2019
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.