RecruitingNot ApplicableNCT04163172

Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures

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


Sponsor

Herlev and Gentofte Hospital

Enrollment

44 participants

Start Date

Feb 1, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria5

  • 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.

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Interventions

PROCEDURESurgical treatment of distal humeral fracture with elbow hemiarthroplasty

Latitude anatomical elbow hemiarthroplasty (WRIGHT -Memphis, Tennessee)

PROCEDURESurgical treatment of distal humeral fracture with double plating.

Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States)


Locations(1)

Herlev and Gentofte University Hospital

Copenhagen, Denmark

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NCT04163172


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