Analysis of fractures around implants and prosthetics in Spain
Peri-Implant and Peri-Prosthetic Fractures: Epidemiology, Morbility, Mortality, Treatment and Functional Outcome Analysis. A Prospective Multi Center Observational Collaborative Study
This study looks at fractures that happen around implants and prosthetics in patients across Spain to find the best ways to treat them and improve recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clínico Universitario de Valladolid Academic / other |
| Locations | 7 sites (Barcelona and 6 other locations) |
| Trial ID | NCT04663893 on ClinicalTrials.gov |
What this trial studies
This observational study collects and analyzes data on periprosthetic and peri-implant fractures of the upper and lower limbs across more than 70 hospitals in Spain. It aims to identify the best treatment options and clinical management strategies for these complex fractures, which often come with significant complications. By evaluating patient health status, quality of life, and treatment outcomes over one month, six months, and one year, the study seeks to establish evidence-based treatment protocols. The findings will help improve patient outcomes, reduce morbidity and mortality, and enhance overall healthcare efficiency.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18 and older diagnosed with periprosthetic or peri-implant fractures of specific upper or lower limb bones.
Not a fit: Patients with fractures related to metastasis, tumors, or those involving the spine, wrist, or hand may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for patients with periprosthetic and peri-implant fractures, enhancing recovery and quality of life.
How similar studies have performed: While there is limited clinical evidence on treatment options for these fractures, this multi-center approach aims to fill that gap, suggesting a novel and potentially impactful investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with the diagnose of Periprosthetic fracture of the shoulder, elbow, hip or knee. Or patients with the diagnose of Peri-implant fracture of the scapula, humerus, forearm, pelvis, femur, patella, tibia or fibula. Or patient presenting cut-out or cut-in after DHS or nail after a proximal humeral fracture. * 18 years or older Exclusion Criteria: * Spine PP or PI fracture * PP or PI secondary to metastasis or tumoral fracture * PP or PI intraoperative fracture * PP or PI pathologic fracture * PP ankle fracture * PP or PI wrist or hand fracture * Fixation failure without any new fracture line: except cut-out or cut-in after DHS or nail of a proximal humeral fracture. * Pregnancy
Where this trial is running
Barcelona and 6 other locations
- Mutua Universitaria de Tarrasa — Barcelona, Spain (Recruiting)
- Althaia, Xarxa Assistencial Universitària de Manresa — Barcelona, Spain (Recruiting)
- Hospital Clinic — Barcelona, Spain (Recruiting)
- Hospital Universitario Vall d´Hebrón — Barcelona, Spain (Recruiting)
- Hospital de Jove — Gijón, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
- Hospital Clínico Universitario de Valladolid — Valladolid, Spain (Recruiting)
Study contacts
- Principal investigator: Josep M Muñoz Vives, MD PhD — Althaia Xarxa Assistencial Universitària de Manresa
- Study coordinator: Adela Pereda-Manso
- Email: aperedama@gmail.com
- Phone: +34983420000
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.