Using bone cement to improve surgery outcomes for hip fractures
Influence of Cemented Cephalic Augmentation on the Outcome of Osteosynthesis Using Intramedullary Nailing in the Surgical Treatment of Pertrochanteric Hip Fractures in the Elderly
NA · Fundacin Biomedica Galicia Sur · NCT06634290
This study is testing if using bone cement during hip fracture surgery can help older patients recover better and avoid complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 314 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Fundacin Biomedica Galicia Sur (other) |
| Locations | 6 sites (Monforte de Lemos, Lugo and 5 other locations) |
| Trial ID | NCT06634290 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether adding bone cement to the intramedullary nailing technique improves surgical outcomes for patients with pertrochanteric hip fractures. Participants aged 75 and older will be randomly assigned to receive either the standard surgical procedure or the modified procedure with bone cement. The study aims to determine if this modification reduces complications related to mechanical failure of the implant and the need for re-operation. The trial will be conducted across multiple hospitals, ensuring a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates are patients aged 75 and older diagnosed with a pertrochanteric fragility fracture requiring surgical intervention.
Not a fit: Patients with hip fractures of subtypes other than those specified or with significant comorbidities that contraindicate surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer complications and re-operations for elderly patients with hip fractures.
How similar studies have performed: While similar approaches have been explored, this specific use of bone cement in intramedullary nailing for this type of fracture is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 75 years of age or older. * Diagnosis with a pertrochanteric fragility fracture. * Informed consent for participation in the study. Exclusion Criteria: * 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.
Where this trial is running
Monforte de Lemos, Lugo and 5 other locations
- Hospital de Monforte de Lemos — Monforte de Lemos, Lugo, Spain (RECRUITING)
- Hospital de Verin — Verín, Ourense, Spain (RECRUITING)
- Complexo Hospitalario Universitario de Vigo — Vigo, Pontevedra, Spain (RECRUITING)
- Hospital do Salnes — Vilagarcía de Arousa, Pontevedra, Spain (RECRUITING)
- Complexo Hospitalario Universitario de Ourense — Ourense, Spain (RECRUITING)
- Complexo Hospitalario Pontevedra — Pontevedra, Spain (RECRUITING)
Study contacts
- Principal investigator: Diego Matias Dominguez Prado, MD, PhD — Complexo Hospitalario de Ourense
- Study coordinator: Diego Matias Dominguez Prado, MD, PhD
- Email: diego.matias.dominguez.prado@sergas.es
- Phone: 34+ 670462170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hip Fracture of Intertrochanteric Type, hip fracture, osteosynthesis, intramedullary nailing, bone cement augmentation