Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Surgical treatment of distal humeral fracture with elbow hemiarthroplasty
Procedure/SurgeryLatitude anatomical elbow hemiarthroplasty (WRIGHT -Memphis, Tennessee)
Surgical treatment of distal humeral fracture with double plating.
Procedure/SurgeryDouble plating (Synthes - Switzerland and West Chester, Pennsylvania, United States)
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Elbow hemiarthroplastyActive comparator 1 intervention
Group B: Open reduction and internal fixationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Oxford Elbow Score (OES)
The OES is a 12-item patient-administrated questionnaire that measures the quality of life in patients with elbow disorder. There are three unidimensional domains: Elbow function, pain, and social-psychological status. Each question is answered on a 5-point scale with each question contributing equally to the total score.Thus, the total score ranges from 12-60, with 60 being the worst. For ease of presentation the score is converted to a scale from 0-48 with 48 being the best. The outcome can be interpreted based on a 48-point scale: 0 - 19 - poor; 20-29 - fair; 30-39 - good; and 40-48 - excellent. The Danish version which will be used in this study, has been translated and cultural adapted according to the guidelines by Guillemin, Bombardier and Beaton.
Time frame
2 years after surgery.Secondary outcomes
1
Mayo Elbow Performance Score (MEPS)
The MEPS is a surgeon-administrated instrument that evaluates the outcome after elbow surgery. There are four domains including: Pain (0-45 points), range of motion (0-20 points), stability (0-10 points) and difficulties in daily activities (0-25 points).The outcome can be interpreted based on a 100 points scale: 0 - 60 - poor; 60-74 - fair; 75-89 - good; and 90-100 - excellent.
Time frame
3 months after surgery and 1, 2, 5, and 10 years after surgery.2
Pain severity score (VAS)
Pain is answered on a visual analogue scale (VAS) ranging from 0 to 10, with 10 being the worst and 0 represents a pain free elbow.
Time frame
3 months after surgery and 1, 2, 5, and 10 years after surgery.3
Range of motion
Measuring the flexion/extension and supination/pronation arcs in degrees.
Time frame
3 months after surgery and 1, 2, 5, and 10 years after surgery.4
Patients satisfaction
Patients satisfaction of the treatment will be recorded using 5-items score with 1 being the worst and 5 represents a very satisfied patient.
Time frame
3 months after surgery and 1, 2, 5, and 10 years after surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov