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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ali.kuthayer.khalil.al-hamdani@regionh.dk
• Phone: 004538673276

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.