Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures

NCT ID: NCT04163172

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2032-12-31

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.

Conditions

Distal Humerus Fracture; Comminuted Fracture; Intra-Articular Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Elbow hemiarthroplasty

The Latitude anatomical hemiarthroplasty (WRIGHT -Memphis, Tennessee) for distal humeral fractures.

Group Type: ACTIVE_COMPARATOR

Surgical treatment of distal humeral fracture with elbow hemiarthroplasty

Intervention Type: PROCEDURE

Latitude anatomical elbow hemiarthroplasty (WRIGHT -Memphis, Tennessee)

Open reduction and internal fixation

Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States) for distal humeral fractures.

Group Type: ACTIVE_COMPARATOR

Surgical treatment of distal humeral fracture with double plating.

Intervention Type: PROCEDURE

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

Interventions

Surgical treatment of distal humeral fracture with elbow hemiarthroplasty

Latitude anatomical elbow hemiarthroplasty (WRIGHT -Memphis, Tennessee)

Intervention Type: PROCEDURE

Surgical treatment of distal humeral fracture with double plating.

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herlev and Gentofte Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ali Al-Hamdani

Medical doctor, shoulder and elbow surgeon.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Al-Hamdani, MD

Role: PRINCIPAL_INVESTIGATOR

Herlev and Gentofte University Hospital

Locations

Herlev and Gentofte University Hospital

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Ali Al-Hamdani, MD

Role: CONTACT

ali.kuthayer.khalil.al-hamdani@regionh.dk

004538673276

Facility Contacts

Ali Al-Hamdani, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 32513252 (View on PubMed)

Other Identifiers

EVORI

Identifier Type: -

Identifier Source: org_study_id