Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorHerlev and Gentofte Hospital
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Surgical treatment of distal humeral fracture with elbow hemiarthroplasty
- Surgical treatment of distal humeral fracture with double plating.
Treatment groups
44 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov