Comparing elbow hemiarthroplasty and ORIF for treating distal humeral fractures in older adults

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 study is testing whether surgery to fix elbow fractures with plates and screws works better than replacing part of the elbow in older adults with these types of injuries.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Herlev and Gentofte Hospital (other)
• Locations: 1 site (Copenhagen)
• Trial ID: NCT04163172 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized control study that compares the outcomes of open reduction and internal fixation (ORIF) with elbow hemiarthroplasty (EHA) for patients aged 50 years and older who have sustained intra-articular distal humeral fractures classified as AO/OTA type C2 or C3. The study aims to determine which surgical approach yields better results in terms of recovery and complications. A total of 44 patients will be enrolled and randomly assigned to receive either ORIF or EHA, with follow-up assessments conducted at multiple intervals post-surgery. The findings could provide valuable insights into the most effective treatment for these complex fractures in the elderly population.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 50 years or older with AO/OTA type C2 or C3 distal humeral fractures.

Not a fit: Patients with significant elbow osteoarthritis, cognitive impairments, or fractures older than 6 weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for older patients with distal humeral fractures.

How similar studies have performed: While there are no direct comparisons of EHA to ORIF in this context, case series have reported promising results for elbow hemiarthroplasty in similar patient populations.

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.

Where this trial is running

Copenhagen

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

Study contacts

• Principal investigator: Ali Al-Hamdani, MD — Herlev and Gentofte University Hospital
• Study coordinator: Ali Al-Hamdani, MD

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