Peri-Implant and Peri-Prosthetic Fractures: Epidemiology, Morbidity, Mortality, Treatment and Outcome Analysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Periprosthetic Fracture of the Upper or Lower Limb, Peri-implant Fracture of the Upper or Lower Limb, Periprosthetic Fractures, Peri-implant Fracture. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Peri-Implant and Peri-Prosthetic Fractures: Epidemiology, Morbility, Mortality, Treatment and Functional Outcome Analysis. A Prospective Multi Center Observational Collaborative Study
Overview
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.
Primary outcome measures
- Mortality [Time frame: Up to 12 months]
- Fracture classification [Time frame: Pre-operatively (Day -1)]
- Treatment [Time frame: Post-operatively (Day +1)]
Secondary outcome measures (8)
- Fracture healing [Time frame: Up to 12 months]
- Health related quality of life [Time frame: Up to 12 months]
- Dependency [Time frame: Up to 12 months]
- Mental situation [Time frame: Up to 12 months]
- Gait [Time frame: Up to 12 months]
- Bone protector treatment [Time frame: Up to 12 months]
- Life style change [Time frame: Up to 12 months]
- Medical or Surgical complications [Time frame: Up to 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Ecologic or community
Study locations
Spain · 7 centers
- Mutua Universitaria de Tarrasa — Barcelona
- Althaia, Xarxa Assistencial Universitària de Manresa — Barcelona
- Hospital Clinic — Barcelona
- Hospital Universitario Vall d´Hebrón — Barcelona
- Hospital de Jove — Gijón
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Clínico Universitario de Valladolid — Valladolid
Publications
- Moreta J, Aguado HJ, Castillon-Bernal P, Munoz-Vives JM, Camacho P, Jornet-Gibert M, Teixidor J, Pereda-Manso A, Garcia-Sanchez Y, Ojeda-Thies C, Garcia-Portabella P, Alvarez EM, Noriega-Gonzalez D, Munoz-Moreno MF, Arroyo-Hernantes I, Alvarez-Ramos BA, Garcia-Medrano B, Martinez-Selles C, Marin-Jimenez S, Garcia-Virto V, Pais-Ortega S, Acha A, Tomas-Hernandez J, Selga-Marsa J, Andres-Peiro JV, Pi PMID 41428314
- 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. PMID 38451303
Identifiers
NCT: NCT04663893 · PI 20-2041