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Peri-Implant and Peri-Prosthe...

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

Last Updated: 2022-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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There is no clinical evidence on which are the best treatment options for Periprosthetic and Peri-implant fractures of the upper and lower limb. This is a multi-center collaborative study seeking to obtain a big number of patients. Data collection includes previous health status and quality of life, which is the clinical management and treatment, as well as the outcome after one month, six months and one year. The investigators will be able to define risk factors and clinical attitudes, which influence on the patient outcome. And therefore, be able to establish treatment protocols and give management recommendations based on the observed clinical evidence to improve healing indexes, morbidity and mortality, function, grade of autonomy and quality of live.

Main questions to be answered are: 1. which is the epidemiology of Periprosthetic and Peri-implant fractures and how are they treated in Spain, 2. Identify risk factors for complications and worse outcomes, 3. which is the morbidity and mortality, 4. influence of the fracture type and implants already placed on management and outcome, 5. influence of the treatment on patients' grade of independency, and 6. identified which are the risk factors for treatment failure.

Conditions

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Periprosthetic Fracture of the Upper or Lower Limb Peri-implant Fracture of the Upper or Lower Limb Periprosthetic Fractures Peri-implant Fracture

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Héctor J Aguado

MD PhD Associate Professor Trauma/Orthogeriatric unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Héctor J Aguado, MD PhD

Role: STUDY_DIRECTOR

Hospital Clínico Universitario Valladolid

Pablo Castillón, MD PhD

Role: STUDY_DIRECTOR

Mútua Universitaria de Terrassa

Josep M Muñoz Vives, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Althaia Xarxa Assistencial Universitària de Manresa

Cristina Ojeda-Thies, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital 12 de Octubre, Madrid

Pilar Camacho, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Jordi Teixidor, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Vall d´Hebrón

Pablo García-Portablella, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Jove, Gijón

Locations

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Mutua Universitaria de Tarrasa

Barcelona, , Spain

Site Status RECRUITING

Althaia, Xarxa Assistencial Universitària de Manresa

Barcelona, , Spain

Site Status RECRUITING

Hospital Clinic

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Vall d´Hebrón

Barcelona, , Spain

Site Status RECRUITING

Hospital de Jove

Gijón, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Adela Pereda-Manso

Role: CONTACT

[email protected]

+34983420000 ext. 86366

Montsant Jornet

Role: CONTACT

[email protected]

Facility Contacts

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Judith López Catena

Role: primary

[email protected]

Josep M Muñoz Vives, MD PhD

Role: primary

[email protected]

Montsant Jornet

Role: primary

[email protected]

Jordi Teixidor, MD

Role: primary

[email protected]

Pablo Garcia-Portabella, MD

Role: primary

[email protected]

Cristina Ojeda-Thies, MD PhD

Role: primary

[email protected]

Adela Pereda Manso

Role: primary

[email protected]

+34983420000 ext. 86366

References

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PIPPAS Study Group. Optimizing periprosthetic fracture management and in-hospital outcome: insights from the PIPPAS multicentric study of 1387 cases in Spain. J Orthop Traumatol. 2024 Mar 7;25(1):13. doi: 10.1186/s10195-024-00746-6.

Reference Type DERIVED

PMID: 38451303 (View on PubMed)

Other Identifiers

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PI 20-2041

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Related Clinical Trials

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Management of Proximal Humerus Fractures in Adults: a Clinical Trial

Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants

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Detailed Description

Conditions

Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

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

Nuestra Señora de Sonsoles Hospital in 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

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

University Hospital of Girona Dr. Josep Trueta

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