An observational study in Periprosthetic Fracture of the Upper or Lower Limb, Peri-implant Fracture of the Upper or Lower Limb and Periprosthetic Fractures, sponsored by Hospital Clínico Universitario de Valladolid. Recruiting at 7 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-01.
Sponsored by Hospital Clínico Universitario de Valladolid · Observational
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.
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.
Hospital Clínico Universitario de Valladolid is the lead sponsor of 21 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients treated for a Periprosthetic or a Peri-implant fracture of the upper or lower limb by any participant hospital in Spain.
Hospital participation is voluntary and upon request or invitation. 80 hospitals participating all over Spain
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mortality
Rate of mortality at anytime from fracture diagnose up to 12 months
Time frame: Up to 12 months
Fracture classification
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: Pre-operatively (Day -1)
Treatment
Number of patients treated with fixation or revision and fixation or implant removal
Time frame: Post-operatively (Day +1)
Fracture healing
Rate of bone union on X-rays
Time frame: Up to 12 months
Health related quality of life
EuroQuality of Life 5Dimensions 5Leves (EQ5D5L)
Time frame: Up to 12 months
Dependency
Clinical frailty scale (1-9) 1=very fit, 9=terminally ill
Time frame: Up to 12 months
Mental situation
Pfeiffer test
Time frame: Up to 12 months
Gait
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
Bone protector treatment
Is the patient under treatment with vitamine D, calcium, bone formation, bone modeling?
Time frame: Up to 12 months
Life style change
Need to change place of living because of the fracture or its sequels.
Time frame: Up to 12 months
Medical or Surgical complications
in need of at least one in-hospital night.
Time frame: Up to 12 months
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: From 1st of January 2022
Access criteria: Application form to the PIPPAS study office. The applicant must be a study participant and should describe which is the substudy to be held, providing a detailed description and variables need for that reason.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Periprosthetic Fractures
Hospital Clínico Universitario de Valladolid