Actively Recruiting
Hip-allograft In Proximal Humerus Fractures Versus Plate Implantation Alone: a Randomized Controlled Trial
Led by Tergooi Medical Center · Updated on 2026-04-20
56
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Proximal humerus fractures (PHFs) are common osteoporotic fractures in adults and the elderly, leading to significant disability and reduced quality of life. Current treatment options for displaced PHFs include locking plate fixation (LCP) and various augmentation techniques, but there is no consensus on the optimal treatment. Although, femoral allografts have shown promising results, there is a need for more definitive evidence regarding the utilization of femoral graft augmentation in addition to locking plate fixation in 3- and 4-part PHFs. This study aims to evaluate the effectiveness of using a mushroom-shaped femoral allograft combined with LCP fixation compared to LCP fixation alone. We hypothesize that femoral allograft augmentation with LCP fixation will result in better clinical and functional outcomes than LCP fixation alone at 24 months post-operative
CONDITIONS
Official Title
Hip-allograft In Proximal Humerus Fractures Versus Plate Implantation Alone: a Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients between 40 and 70 years old
- Acute (less than 3 weeks) 3- or 4-part proximal humerus fracture (NEER classification)
- Ability to understand and communicate in Dutch
- Competent to make decisions
- Willing and able to complete study procedures
- Provide written informed consent
You will not qualify if you...
- Head-split fractures
- Pathological fractures due to malignancy or metastases
- Diagnosis of dementia, cognitive impairment, or residing in institutional care
- Terminal illness
- Convulsive disorders, collagen diseases, or other conditions affecting shoulder mobility
- Active joint or systemic infection
- History of prior surgery on the same shoulder
- Previous fracture in the same shoulder
- Psychiatric illness preventing informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tergooi Medical Center
Hilversum, Netherlands
Actively Recruiting
Research Team
D
Dominique C Baas, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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