Clinical trial NCT04663893: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Periprosthetic Fracture of the Upper or Lower Limb
Peri-implant Fracture of the Upper or Lower Limb
Periprosthetic Fractures
Peri-implant Fracture
Keywords: Periprosthetic fracture
peri-implant fracture
mortality
morbidity
loosening
prosthesis revision
fixation
osteosynthesis
complication
ambulate
quality of life
Lead sponsor: Hospital Clínico Universitario de Valladolid
Sponsor class: OTHER
Collaborators: name: Hospital Mutua de Terrassa
name: Althaia Xarxa Assistencial Universitària de Manresa
name: Hospital Clinic of Barcelona
name: Hospital Universitario 12 de Octubre
name: Hospital Vall d'Hebron
name: Hospital de Jove, Gijón, Spain
name: Hospital de Basurto
name: Hospital Álvaro Cunqueiro
name: Hospital Galdakao-Usansolo
name: Hospital Universitario de Canarias
name: Hospital Infanta Elena de Valdemoro, Madrid
name: Hospital Universitario Doctor Peset
name: Hospital Royo Villanova - Ntra. Sra. de Gracia, Zaragoza
name: Hospital Universitario de Cabueñes, Asturias
name: Hospital Universitario Fundación Alcorcón, Madrid
name: Nuestra Señora de Sonsoles Hospital in Ávila
name: Hospital Clínico Universitario San Carlos, Madrid
name: Complejo Hospitalario Universitario, A Coruña
name: Hospital Gregorio Marañón, Madrid
name: Hospital Universitario de Álava - Txagorritxu, Alava
name: Hospital Universitario General de Elche, Elche
name: Hospital Gral. Univ. Los Arcos del Mar Menor de Murcia
name: Hospital Vega Baja de Orihuela, Alicante
name: Hospital Gral. Univ. Morales Meseguer, Murcia
name: Hospital Can Misses, Ibiza
name: Hospital Son Llàtzer, Palma de Mallorca
name: Hospital Marqués de Valdecilla, Santander
name: Hospital Virgen de la Salud
name: Hospital Puerta de Hierro, Madrid
name: Hospital General de Segovia
name: Hospital Moisés Broggi de Sant Joan Despí, Barcelona
name: Hospital Universitari Sagrat Cor, Barcelona
name: Complejo Hospitalario Llerena-Zafra, Badajoz
name: Hospital Universitario Lucus Augusti
name: Hospital Universitario La Paz
name: Hospital Universitario Ramón y Cajal de Madrid
name: Hospital Universitario Pcpe. de Asturias de Alcalá de Henares, Madrid
name: Hospital General Universitario Reina Sofía, Murcia
name: Hospital General Obispo Polanco, Teruel
name: Hospital Universitario de Guadalajara
name: Hospital Josep Trueta, Girona
name: Complejo Hospitalario Universitario de Albacete
name: Hospital Sierrallana de Torrelavega, Cantabria
name: Complejo Hospitalario de Palencia
name: Hospital Universitario Fundación Jiménez Díaz, Madrid
name: Complexo Hospitalario Universitario de Pontevedra
name: Hospital Parc Taulí de Sabadell, Barcelona
name: Hospital Universitario Miguel Servet, Zaragoza
name: Hospital Universitari Arnau de Vilanova, Lleida
name: Hospital Universitario de León
name: Hospital Universitario de Burgos
name: Hospital Santa Bárbara, Soria
name: Hospital San Pedro de Logroño
name: Hospital Costa del Sol de Marbella, Málaga
name: Hospital Parc De Salut Mar, Barcelona
name: Hospital Italiano de Buenos Aires, Argentina
name: Complejo Hospitalario de Navarra
name: Hospital Santos Reyes de Aranda de Duero, Burgos
name: Hospitales Universitarios Virgen del Rocío
name: Hospital de la Santa creu i Sant Pau - Barcelona
name: Hospital Universitario Dr. Negrín, Gran Canaria
name: Hospital Universitario Infanta Leonor, Madrid
name: Hospital Comarcal Alto Guadalquivir de Andújar, Jaén
name: Hospital Universitario de Donostia, Guipúzcoa
name: Hospital Carmen y Severo Ochoa de Cangas de Narcea, Asturias
name: Hospital Reina Sofía de Tudela, Navarra
name: Hospital Universitario San Agustín de Avilés, Asturias
name: Hospital Universitario Virgen de la Macarena, Sevilla
name: Hospital Universitario El Escorial, Madrid
First posted: 2020-12-11
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated for a Periprosthetic or a Peri-implant fracture of the upper or lower limb by any participant hospital in Spain.

Hospital participation is voluntary and upon request or invitation. 80 hospitals participating all over Spain

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Mortality
timeFrame: Up to 12 months
measure: Fracture classification
timeFrame: Pre-operatively (Day -1)
measure: Treatment
timeFrame: Post-operatively (Day +1)
Secondary outcomes:
measure: Fracture healing
timeFrame: Up to 12 months
measure: Health related quality of life
timeFrame: Up to 12 months
measure: Dependency
timeFrame: Up to 12 months
measure: Mental situation
timeFrame: Up to 12 months
measure: Gait
timeFrame: Up to 12 months
measure: Bone protector treatment
timeFrame: Up to 12 months
measure: Life style change
timeFrame: Up to 12 months
measure: Medical or Surgical complications
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Mutua Universitaria de Tarrasa
city: Barcelona
country: Spain
facility: Althaia, Xarxa Assistencial Universitària de Manresa
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d´Hebrón
city: Gijón
country: Spain
facility: Hospital de Jove
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
affiliation: Hospital Clínico Universitario Valladolid
name: Héctor J Aguado, MD PhD
role: STUDY_DIRECTOR
affiliation: Mútua Universitaria de Terrassa
name: Pablo Castillón, MD PhD
role: STUDY_DIRECTOR
affiliation: Althaia Xarxa Assistencial Universitària de Manresa
name: Josep M Muñoz Vives, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital 12 de Octubre, Madrid
name: Cristina Ojeda-Thies, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Pilar Camacho, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Vall d´Hebrón
name: Jordi Teixidor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Jove, Gijón
name: Pablo García-Portablella, MD
role: PRINCIPAL_INVESTIGATOR
References: