Actively Recruiting
Influence of Cemented Cephalic Augmentation on the Outcome of Intramedullary Nailing in Pertrochanteric Hip Fractures
Led by Diego Matías Domínguez Prado · Updated on 2024-10-09
314
Participants Needed
6
Research Sites
100 weeks
Total Duration
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AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if small modifications in the surgical technique for the treatment of some kind of hip fractures, improve the result of the surgery. This small modification includes the addition of surgical bone cement to part of the intramedullary nail used in the surgery, to find out if it provides more stability to the construct and represents an improvement in the surgery result. The main question it aims to answer is: Does the addition of bone cement produces a decrease in complications related to mechanical failure of the implant used in the surgery and a decrease in the need for re-operation? Researchers will compare adding this bone cement to the standard surgical technique without it. Patients will: * Be randomly assigned to a group that will have surgery following standard protocol or to a group that will have surgery following standard protocol but adding bone cement to the construct. * Receive standard care for these fractures during hospitalization and posterior follow-up checkups for a year.
CONDITIONS
Official Title
Influence of Cemented Cephalic Augmentation on the Outcome of Intramedullary Nailing in Pertrochanteric Hip Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 75 years of age or older.
- Diagnosis with a pertrochanteric fragility fracture.
- Informed consent for participation in the study.
You will not qualify if you...
- Not meeting the inclusion criteria described above.
- Refusal of the patient or his/her legal representative to participate in the study.
- Diagnosis with hip fracture of subtypes other than 31A1, 31A2, 31A3 and 31B3 of AO-OTA classification.
- Bilateral hip fractures in the same episode.
- Suffering from previous medical pathologies or comorbidities that contraindicate surgical intervention and indicate conservative management of the fracture.
- Performing a surgical technique different from intramedullary nailing or using a surgical implant different from that used in the present study.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Hospital de Monforte de Lemos
Monforte de Lemos, Lugo, Spain, 27400
Actively Recruiting
2
Hospital de Verin
Verín, Ourense, Spain, 32600
Actively Recruiting
3
Complexo Hospitalario Universitario de Vigo
Vigo, Pontevedra, Spain, 36312
Actively Recruiting
4
Hospital do Salnes
Vilagarcía de Arousa, Pontevedra, Spain, 36619
Actively Recruiting
5
Complexo Hospitalario Universitario de Ourense
Ourense, Spain, 32005
Actively Recruiting
6
Complexo Hospitalario Pontevedra
Pontevedra, Spain, 36071
Actively Recruiting
Research Team
D
Diego Matias Dominguez Prado, MD, 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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