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

Hospital Clínico Universitario de Valladolid

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT04663893

PI 20-2041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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