NCT Number: NCT04663893
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Althaia, Xarxa Assistencial Universitària de Manresa, Barcelona, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to 12 months
Rate of mortality at anytime from fracture diagnose up to 12 months
Time frame: Pre-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
Time frame: Post-operatively (Day +1)
Number of patients treated with fixation or revision and fixation or implant removal
Time frame: Up to 12 months
Rate of bone union on X-rays
Time frame: Up to 12 months
EuroQuality of Life 5Dimensions 5Leves (EQ5D5L)
Time frame: Up to 12 months
Clinical frailty scale (1-9) 1=very fit, 9=terminally ill
Time frame: Up to 12 months
Pfeiffer test
Time frame: Up to 12 months
FFN-MCD mobility scale (Fragility Fracture Network-Minimum Common Dataset). 1-5: 1=independent mobility, 5=No functional mobility
Time frame: Up to 12 months
Is the patient under treatment with vitamine D, calcium, bone formation, bone modeling?
Time frame: Up to 12 months
Need to change place of living because of the fracture or its sequels.
Time frame: Up to 12 months
in need of at least one in-hospital night.
Contact information is provided by the study sponsor or research team.
Hospital Clínico Universitario de Valladolid
Other
Peri-Implant and Peri-Prosthetic Fractures: Epidemiology, Morbility, Mortality, Treatment and Functional Outcome Analysis. A Prospective Multi Center Observational Collaborative Study
Acronym: PIPPAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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