Randomized Trial Comparing Elbow Hemiarthroplasty and Open Reduction Internal Fixation for Complex Distal Humerus Fractures in Patients 50 Years and Older
Led by Herlev and Gentofte Hospital · Updated on 2023-10-06
44
Participants Needed
1
Research Sites
313 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to compare two surgical treatments for distal humeral fractures, specifically AOOTA type C2 and C3 fractures, in patients aged 50 years or older. These fractures are challenging to treat, and while open reduction and internal fixation ORIF is often preferred, results can vary. Elbow hemiarthroplasty EHA is a newer option that may avoid some complications seen with total elbow arthroplasty, especially in active patients. This trial investigates which treatment provides better outcomes for these complex fractures.
Participants will be randomly assigned to receive either elbow hemiarthroplasty using the Latitude anatomical device or ORIF with double plating implants. The study involves surgical procedures using devices from Wright for EHA and Synthes for ORIF. After surgery, patients will be followed up and evaluated at 3 months and then at 1, 2, 5, and 10 years to assess long-term results.
During the study, patients will undergo examinations including functional scoring with the Oxford Elbow Score at 2 years after surgery, along with secondary assessments such as the Mayo Elbow Performance Score, pain severity using a visual scale, range of motion, and patient satisfaction at multiple time points. These evaluations aim to understand the effectiveness and patient experience related to each surgical treatment. The total follow-up period extends up to 10 years to monitor outcomes and safety over time.
CONDITIONS
Brief Title
Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures
Research Team
A
Ali Al-Hamdani, MD
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Distal humeral fracture AO/OTA type C2 or C3 confirmed by plain radiographs and CT scan
ASA score between 1 and 3 and physically fit for surgery
Age of 50 years or above
You will not qualify if you...
Unable to follow rehabilitation protocol or answer questionnaires due to physical or cognitive impairments
Significant elbow osteoarthritis based on radiographs and CT scan
Fractures older than 6 weeks
Other associated elbow fractures
Pathological fractures or relevant elbow pathology
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery plus immediate recovery period
Participants receive surgical treatment for distal humeral fractures with either elbow hemiarthroplasty or open reduction and internal fixation.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - Up to 10 years after surgery
Participants are examined and assessed after surgery to monitor recovery and outcomes.
Visits at 3 months, 1 year, 2 years, 5 years, and 10 years after surgery
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Randomized Trial Comparing Elbow Hemiarthroplasty and Open Reduction Internal Fixation for Complex Distal Humerus Fractures in Patients 50 Years and Older
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Published Research Related To This Trial
Elbow hemiarthroplasty versus open reduction and internal fixation for AO/OTA type 13 C2 and C3 fractures of distal humerus in patients aged 50 years or above: a randomized controlled trial.
Ali Al-Hamdani, Jeppe V Rasmussen, Kenneth Holtz...