Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intra-Articular Fractures; Distal Humerus Fracture; Comminuted Fracture
• Intervention / Treatment: Procedure: Surgical treatment of distal humeral fracture with elbow hemiarthroplasty; Procedure: Surgical treatment of distal humeral fracture with double plating.

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ali Al-Hamdani, MD; Phone Number: 004538673276; Email: ali.kuthayer.khalil.al-hamdani@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Herlev and Gentofte University Hospital
    • Contact: Ali Al-Hamdani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Elbow hemiarthroplasty; The Latitude anatomical hemiarthroplasty (WRIGHT -Memphis, Tennessee) for distal humeral fractures.	Procedure: Surgical treatment of distal humeral fracture with elbow hemiarthroplasty; Latitude anatomical elbow hemiarthroplasty (WRIGHT -Memphis, Tennessee)
Active Comparator: Open reduction and internal fixation; Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States) for distal humeral fractures.	Procedure: Surgical treatment of distal humeral fracture with double plating.; Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Elbow Score (OES)	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.	2 years after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mayo Elbow Performance Score (MEPS)	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.	3 months after surgery and 1, 2, 5, and 10 years after surgery.
Pain severity score (VAS)	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 months after surgery and 1, 2, 5, and 10 years after surgery.
Range of motion	Measuring the flexion/extension and supination/pronation arcs in degrees.	3 months after surgery and 1, 2, 5, and 10 years after surgery.
Patients satisfaction	Patients satisfaction of the treatment will be recorded using 5-items score with 1 being the worst and 5 represents a very satisfied patient.	3 months after surgery and 1, 2, 5, and 10 years after surgery.

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital
• Investigators: Principal Investigator: Ali Al-Hamdani, MD, Herlev and Gentofte University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Elbow Injuries; Elbow Fractures; Fractures, Bone; Humeral Fractures; Intra-Articular Fractures; Fractures, Comminuted; Humeral Fractures, Distal
• Other Study ID Numbers: EVORI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No