Observational Recruiting
NCT04663893 on ClinicalTrials.gov
Peri-Implant and Peri-Prosthetic Fractures: Epidemiology, Morbidity, Mortality, Treatment and Outcome Analysis
Official title: Peri-Implant and Peri-Prosthetic Fractures: Epidemiology, Morbility, Mortality, Treatment and Functional Outcome Analysis. A Prospective Multi Center Observational Collaborative Study
- Sponsor: Hospital Clínico Universitario de Valladolid
- Collaborators: Hospital Mutua de Terrassa, Althaia Xarxa Assistencial Universitària de Manresa, Hospital Clinic of Barcelona, Hospital Universitario 12 de Octubre, Hospital Vall d'Hebron, Hospital de Jove, Gijón, Spain, Hospital de Basurto, Hospital Álvaro Cunqueiro, Hospital Galdakao-Usansolo, Hospital Universitario de Canarias, Hospital Infanta Elena de Valdemoro, Madrid, Hospital Universitario Doctor Peset, Hospital Royo Villanova - Ntra. Sra. de Gracia, Zaragoza, Hospital Universitario de Cabueñes, Asturias, Hospital Universitario Fundación Alcorcón, Madrid, Hospital Nuestra Señora de Sonsoles, Ávila, Hospital Clínico Universitario San Carlos, Madrid, Complejo Hospitalario Universitario, A Coruña, Hospital Gregorio Marañón, Madrid, Hospital Universitario de Álava - Txagorritxu, Alava, Hospital Universitario General de Elche, Elche, Hospital Gral. Univ. Los Arcos del Mar Menor de Murcia, Hospital Vega Baja de Orihuela, Alicante, Hospital Gral. Univ. Morales Meseguer, Murcia, Hospital Can Misses, Ibiza, Hospital Son Llàtzer, Palma de Mallorca, Hospital Marqués de Valdecilla, Santander, Hospital Virgen de la Salud, Hospital Puerta de Hierro, Madrid, Hospital General de Segovia, Hospital Moisés Broggi de Sant Joan Despí, Barcelona, Hospital Universitari Sagrat Cor, Barcelona, Complejo Hospitalario Llerena-Zafra, Badajoz, Hospital Universitario Lucus Augusti, Lugo, Hospital Universitario La Paz, Hospital Universitario Ramón y Cajal de Madrid, Hospital Universitario Pcpe. de Asturias de Alcalá de Henares, Madrid, Hospital General Universitario Reina Sofía, Murcia, Hospital General Obispo Polanco, Teruel, Hospital Universitario de Guadalajara, Hospital Josep Trueta, Girona, Complejo Hospitalario Universitario de Albacete, Hospital Sierrallana de Torrelavega, Cantabria, Complejo Hospitalario de Palencia, Hospital Universitario Fundación Jiménez Díaz, Madrid, Complexo Hospitalario Universitario de Pontevedra, Hospital Parc Taulí de Sabadell, Barcelona, Hospital Universitario Miguel Servet, Zaragoza, Hospital Universitari Arnau de Vilanova, Lleida, Hospital Universitario de León, Hospital Universitario de Burgos, Hospital Santa Bárbara, Soria, Hospital San Pedro de Logroño, Hospital Costa del Sol de Marbella, Málaga, Hospital Parc De Salut Mar, Barcelona, Hospital Italiano de Buenos Aires, Argentina, Complejo Hospitalario de Navarra, Hospital Santos Reyes de Aranda de Duero, Burgos, Hospitales Universitarios Virgen del Rocío, Hospital de la Santa creu i Sant Pau - Barcelona, Hospital Universitario Dr. Negrín, Gran Canaria, Hospital Universitario Infanta Leonor, Madrid, Hospital Comarcal Alto Guadalquivir de Andújar, Jaén, Hospital Universitario de Donostia, Guipúzcoa, Hospital Carmen y Severo Ochoa de Cangas de Narcea, Asturias, Hospital Reina Sofía de Tudela, Navarra, Hospital Universitario San Agustín de Avilés, Asturias, Hospital Universitario Virgen de la Macarena, Sevilla, Hospital Universitario El Escorial, Madrid
- Enrollment: 2500 (Estimated)
- Study start: 2021-01-01 (Actual)
- Primary completion: 2022-12-31 (Estimated)
- Study completion: 2027-12-31 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
Brief 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.
Conditions
- Periprosthetic Fracture of the Upper or Lower Limb
- Peri-implant Fracture of the Upper or Lower Limb
- Periprosthetic Fractures
- Peri-implant Fracture
Primary Outcome Measures
-
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
Countries
Spain
Locations and Investigators
-
Mutua Universitaria de Tarrasa, Barcelona, Spain (Recruiting)
- Judith López Catena
- Pablo Castillón, MD PhD (Principal Investigator)
- Judith López Catena, PhD
-
Althaia, Xarxa Assistencial Universitària de Manresa, Barcelona, Spain (Recruiting)
- Josep M Muñoz Vives, MD PhD
- Josep M Muñoz Vives, MD PhD (Principal Investigator)
-
Hospital Clinic, Barcelona, Spain (Recruiting)
- Montsant Jornet
- Pilar Camacho, MD PhD (Principal Investigator)
- Montsant Jornet
-
Hospital Universitario Vall d´Hebrón, Barcelona, Spain (Recruiting)
- Jordi Teixidor, MD
- Jordi Teixidor, MD (Principal Investigator)
-
Hospital de Jove, Gijón, Spain (Recruiting)
- Pablo Garcia-Portabella, MD
- Pablo Garcia-Portabella, MD (Principal Investigator)
-
Hospital Universitario 12 de Octubre, Madrid, Spain (Recruiting)
- Cristina Ojeda-Thies, MD PhD
- Cristina Ojeda-Thies, MD PhD (Principal Investigator)
-
Hospital Clínico Universitario de Valladolid, Valladolid, Spain (Recruiting)
- Adela Pereda Manso
- Héctor J Aguado, MD PhD (Principal Investigator)
- Adela Pereda
Study Officials
- Héctor J Aguado, MD PhD (Study Director) — Hospital Clínico Universitario Valladolid
- Pablo Castillón, MD PhD (Study Director) — Mútua Universitaria de Terrassa
- Josep M Muñoz Vives, MD PhD (Principal Investigator) — Althaia Xarxa Assistencial Universitària de Manresa
- Cristina Ojeda-Thies, MD PhD (Principal Investigator) — Hospital 12 de Octubre, Madrid
- Pilar Camacho, MD PhD (Principal Investigator) — Hospital Clinic of Barcelona
- Jordi Teixidor, MD (Principal Investigator) — Hospital Universitario Vall d´Hebrón
- Pablo García-Portablella, MD (Principal Investigator) — Hospital de Jove, Gijón