NCT04163172 Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures
| NCT ID | NCT04163172 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Herlev and Gentofte Hospital |
| Condition | Distal Humerus Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2020-02-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2020-02-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Ali Al-Hamdani, MD
PRINCIPAL INVESTIGATOR
Herlev and Gentofte University Hospital
Frequently Asked Questions
Who can join the NCT04163172 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Distal Humerus Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04163172 currently recruiting?
Yes, NCT04163172 is actively recruiting participants. Contact the research team at ali.kuthayer.khalil.al-hamdani@regionh.dk for enrollment information.
Where is the NCT04163172 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT04163172 clinical trial?
NCT04163172 is sponsored by Herlev and Gentofte Hospital. The principal investigator is Ali Al-Hamdani, MD at Herlev and Gentofte University Hospital. The trial plans to enroll 44 participants.