Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures

Not Applicable

Recruiting

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

• Registration Number: NCT04163172
• Lead Sponsor: Herlev and Gentofte Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-14
• Study Start: 2020-02-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06
• Primary Completion: 2026-12-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Oxford Elbow Score (OES)	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 Outcome Measures

Name	Time	Method
Mayo Elbow Performance Score (MEPS)	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.
Pain severity score (VAS)	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.
Range of motion	3 months after surgery and 1, 2, 5, and 10 years after surgery.	Measuring the flexion/extension and supination/pronation arcs in degrees.
Patients satisfaction	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.

Trial Locations

Locations (1)

Herlev and Gentofte University Hospital; 🇩🇰 Copenhagen, Denmark