Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures

Distal Humerus Fracture Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04163172
• Other study ID #: EVORI
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: December 31, 2032

Study information

• Verified date: October 2023
• Source: Herlev and Gentofte Hospital
• Contact: Ali Al-Hamdani, MD
• Phone: 004538673276
• Email: ali.kuthayer.khalil.al-hamdani[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Comminuted Fracture
• Distal Humerus Fracture
• Fractures, Bone
• Fractures, Comminuted
• Humeral Fractures
• Intra-Articular Fractures

Intervention

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

Locations

Country	Name	City	State
Denmark	Herlev and Gentofte University Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.