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

Peri-Implant and Peri-Prosthetic Fractures: Epidemiology, Morbility, Mortality, Treatment and Functional Outcome Analysis. A Prospective Multi Center Observational Collaborative Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04663893
Acronym
PIPPAS
Enrollment
2500
Registered
2020-12-11
Start date
2021-01-01
Completion date
2027-12-31
Last updated
2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Periprosthetic fracture, peri-implant fracture, mortality, morbidity, loosening, prosthesis revision, fixation, osteosynthesis, complication, ambulate, quality of life

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.

Interventions

None listed

Sponsors

Hospital Mutua de Terrassa
CollaboratorOTHER
Althaia Xarxa Assistencial Universitària de Manresa
CollaboratorOTHER
Hospital Clinic of Barcelona
CollaboratorOTHER
Hospital Universitario 12 de Octubre
CollaboratorOTHER
Hospital Vall d'Hebron
CollaboratorOTHER
Hospital de Jove, Gijón, Spain
CollaboratorUNKNOWN
Hospital de Basurto
CollaboratorOTHER
Hospital Álvaro Cunqueiro
CollaboratorOTHER
Hospital Galdakao-Usansolo
CollaboratorOTHER_GOV
Hospital Universitario de Canarias
CollaboratorOTHER
Hospital Infanta Elena de Valdemoro, Madrid
CollaboratorUNKNOWN
Hospital Universitario Doctor Peset
CollaboratorOTHER
Hospital Royo Villanova - Ntra. Sra. de Gracia, Zaragoza
CollaboratorUNKNOWN
Hospital Universitario de Cabueñes, Asturias
CollaboratorUNKNOWN
Hospital Universitario Fundación Alcorcón, Madrid
CollaboratorUNKNOWN
Nuestra Señora de Sonsoles Hospital in Ávila
CollaboratorOTHER
Hospital Clínico Universitario San Carlos, Madrid
CollaboratorUNKNOWN
Complejo Hospitalario Universitario, A Coruña
CollaboratorUNKNOWN
Hospital Gregorio Marañón, Madrid
CollaboratorUNKNOWN
Hospital Universitario de Álava - Txagorritxu, Alava
CollaboratorUNKNOWN
Hospital Universitario General de Elche, Elche
CollaboratorUNKNOWN
Hospital Gral. Univ. Los Arcos del Mar Menor de Murcia
CollaboratorUNKNOWN
Hospital Vega Baja de Orihuela, Alicante
CollaboratorUNKNOWN
Hospital Gral. Univ. Morales Meseguer, Murcia
CollaboratorUNKNOWN
Hospital Can Misses, Ibiza
CollaboratorUNKNOWN
Hospital Son Llàtzer, Palma de Mallorca
CollaboratorUNKNOWN
Hospital Marqués de Valdecilla, Santander
CollaboratorUNKNOWN
Hospital Virgen de la Salud
CollaboratorOTHER
Hospital Puerta de Hierro, Madrid
CollaboratorUNKNOWN
Hospital General de Segovia
CollaboratorOTHER
Hospital Moisés Broggi de Sant Joan Despí, Barcelona
CollaboratorUNKNOWN
Hospital Universitari Sagrat Cor, Barcelona
CollaboratorUNKNOWN
Complejo Hospitalario Llerena-Zafra, Badajoz
CollaboratorUNKNOWN
Hospital Universitario Lucus Augusti
CollaboratorOTHER
Hospital Universitario La Paz
CollaboratorOTHER
Hospital Universitario Ramón y Cajal de Madrid
CollaboratorUNKNOWN
Hospital Universitario Pcpe. de Asturias de Alcalá de Henares, Madrid
CollaboratorUNKNOWN
Hospital General Universitario Reina Sofía, Murcia
CollaboratorUNKNOWN
Hospital General Obispo Polanco, Teruel
CollaboratorUNKNOWN
Hospital Universitario de Guadalajara
CollaboratorUNKNOWN
University Hospital of Girona Dr. Josep Trueta
CollaboratorNETWORK
Complejo Hospitalario Universitario de Albacete
CollaboratorOTHER
Hospital Sierrallana de Torrelavega, Cantabria
CollaboratorUNKNOWN
Complejo Hospitalario de Palencia
CollaboratorUNKNOWN
Hospital Universitario Fundación Jiménez Díaz, Madrid
CollaboratorUNKNOWN
Complexo Hospitalario Universitario de Pontevedra
CollaboratorUNKNOWN
Hospital Parc Taulí de Sabadell, Barcelona
CollaboratorUNKNOWN
Hospital Universitario Miguel Servet, Zaragoza
CollaboratorUNKNOWN
Hospital Universitari Arnau de Vilanova, Lleida
CollaboratorUNKNOWN
Hospital Universitario de León
CollaboratorUNKNOWN
Hospital Universitario de Burgos
CollaboratorOTHER
Hospital Santa Bárbara, Soria
CollaboratorUNKNOWN
Hospital San Pedro de Logroño
CollaboratorOTHER
Hospital Costa del Sol de Marbella, Málaga
CollaboratorUNKNOWN
Hospital Parc De Salut Mar, Barcelona
CollaboratorUNKNOWN
Hospital Italiano de Buenos Aires, Argentina
CollaboratorUNKNOWN
Complejo Hospitalario de Navarra
CollaboratorOTHER
Hospital Santos Reyes de Aranda de Duero, Burgos
CollaboratorUNKNOWN
Hospitales Universitarios Virgen del Rocío
CollaboratorOTHER
Hospital de la Santa creu i Sant Pau - Barcelona
CollaboratorOTHER
Hospital Universitario Dr. Negrín, Gran Canaria
CollaboratorUNKNOWN
Hospital Universitario Infanta Leonor, Madrid
CollaboratorUNKNOWN
Hospital Comarcal Alto Guadalquivir de Andújar, Jaén
CollaboratorUNKNOWN
Hospital Universitario de Donostia, Guipúzcoa
CollaboratorUNKNOWN
Hospital Carmen y Severo Ochoa de Cangas de Narcea, Asturias
CollaboratorUNKNOWN
Hospital Reina Sofía de Tudela, Navarra
CollaboratorUNKNOWN
Hospital Universitario San Agustín de Avilés, Asturias
CollaboratorUNKNOWN
Hospital Universitario Virgen de la Macarena, Sevilla
CollaboratorUNKNOWN
Hospital Universitario El Escorial, Madrid
CollaboratorUNKNOWN
Hospital Clínico Universitario de Valladolid
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
MortalityUp to 12 monthsRate of mortality at anytime from fracture diagnose up to 12 months
Fracture classificationPre-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
TreatmentPost-operatively (Day +1)Number of patients treated with fixation or revision and fixation or implant removal

Secondary

MeasureTime frameDescription
Mental situationUp to 12 monthsPfeiffer test
GaitUp to 12 monthsFFN-MCD mobility scale (Fragility Fracture Network-Minimum Common Dataset). 1-5: 1=independent mobility, 5=No functional mobility
Fracture healingUp to 12 monthsRate of bone union on X-rays
Life style changeUp to 12 monthsNeed to change place of living because of the fracture or its sequels.
Medical or Surgical complicationsUp to 12 monthsin need of at least one in-hospital night.
Bone protector treatmentUp to 12 monthsIs the patient under treatment with vitamine D, calcium, bone formation, bone modeling?
Health related quality of lifeUp to 12 monthsEuroQuality of Life 5Dimensions 5Leves (EQ5D5L)
DependencyUp to 12 monthsClinical frailty scale (1-9) 1=very fit, 9=terminally ill

Countries

Spain

Contacts

Primary ContactAdela Pereda-Manso
aperedama@gmail.com+34983420000
Backup ContactMontsant Jornet
estudio.pippas@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026