Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures

Recruiting now · Not applicable

Conditions studied: Distal Humerus Fracture, Comminuted Fracture, Intra-Articular Fractures

In brief

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.

Key facts

Study ID

NCT04163172

Run by

Herlev and Gentofte Hospital

People needed

44

Starts

2020-02-01

Expected to finish

2032-12-31

Last updated by the study team

2023-10-06

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Herlev and Gentofte University Hospital — Copenhagen, Denmark (enrolling)

Full record on ClinicalTrials.gov

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