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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    2500
  • sponsor
    Hospital Clínico Universitario de Valladolid
Updated on 24 March 2022
humeral fracture

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.

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.

Details
Condition Periprosthetic Fracture of the Upper or Lower Limb, Peri-implant Fracture of the Upper or Lower Limb, Periprosthetic Fractures, Peri-implant Fracture
Clinical Study IdentifierNCT04663893
SponsorHospital Clínico Universitario de Valladolid
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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
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
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Step 1 Connect with a study center
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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