Ireland
--:--IST
Recruiting Observational

Peri-Implant and Peri-Prosthetic Fractures: Epidemiology, Morbidity, Mortality, Treatment and Outcome Analysis

NCT04663893 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2021-01-01
Last updated
2022-02-01

Condition(s) studied

Periprosthetic Fracture of the Upper or Lower LimbPeri-implant Fracture of the Upper or Lower LimbPeriprosthetic FracturesPeri-implant Fracture

Study summary

This study supports Spanish data collection and analysis on Periprosthetic and Peri-implant fractures of the upper and lower limb. Treatment and clinical management of this fractures are complex and goes along with complications. There will be more than 70 hospitals providing information. This study will provide evidence on which is the best treatment for every unique patient. This will help trauma surgeons and geriatricians to provide better treatments, to improve health care in our society, reducing mortality, morbidity, improving functional outcomes, and reducing costs, which in turn will be advances in trauma care.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Mortality — Up to 12 months
    Rate of mortality at anytime from fracture diagnose up to 12 months
  • Fracture classification — Pre-operatively (Day -1)
    Fracture classification using the UCS for periprosthetic fractures, and the adapted H. Broggi classification for peri-implant fractures. Number of patients in each classification group
  • Treatment — Post-operatively (Day +1)
    Number of patients treated with fixation or revision and fixation or implant removal

Trial sites (7)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04663893 on ClinicalTrials.gov ↗ ← All trials in Spain