Periprosthetic Fracture Registry (PPFx)
- Conditions
- Periprosthetic Fracture Around Prosthetic Joint ImplantPeriprosthetic Fractures
- Registration Number
- NCT03378557
- Lead Sponsor
- AO Innovation Translation Center
- Brief Summary
This registry supports international data collection and research on PPFx treatments after hip and knee arthroplasty.
A registry such as this ultimately aims to provide far-reaching benefits to society including reduced morbidity and mortality, improved patient safety, improved quality of care and medical decision-making, reduced medical spending, and advances in orthopaedic science.
- Detailed Description
To close the gap of missing clinical evidence regarding the treatment of periprosthetic fractures after arthroplasty of the hip or the knee with osteosynthesis.
To drive further study hypotheses and to answer unforeseen questions.
Main questions to be answered by the registry include (but are not exclusive) the following:
1. Influence of implants on outcome
2. Influence of surgical techniques on outcome
3. Influence of bone grafting on outcome
4. Identification of risk factors for failure
5. Identification of postoperative rehabilitation programs and its possible influence on the outcome
6. Influence of fracture type on outcome
7. To serve as a comparative dataset for future studies with improved implants and techniques
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
-
Age ≥18 years
-
Post-operative PPFx after total or hemi hip or total or unicondylar knee arthroplasty (including the acetabulum, femur, patella and proximal tibia) requiring
- osteosynthesis alone or
- component revision plus plate/nail osteosynthesis
-
Informed consent obtained, i.e.:
- Ability of the patient or assigned representative to understand the content of the patient information / Informed Consent Form
- Signed and dated EC / IRB approved written informed consent
-
Ability to attend post-operative follow up visits
-
- Pregnancy or women planning to conceive within the study period
- Prisoner
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Classification of the fracture Pre-operatively (Day -1) Classification of the fracture using the UCS and some parts of the AO/OTA fracture classification system.
- Secondary Outcome Measures
Name Time Method Function of hip or knee Up to 12 months Harris Hip Score or Knee Society score
Fracture healing Up to 12 months by RUSH or RUST score
pain visual analog scale (VAS) and pain medication Up to 12 months Using the pain visual analog scale (VAS) and pain medication
Fracture mechanism Pre-operatively (Day -1) High / low energy trauma, pathological fracture, stem stability
Health related quality of life Up to 12 months PROMIS pain interference and physical activity
Rehabilitation program Up to 12 months weight bearing, bedrest, splint
Trial Locations
- Locations (13)
Charité Universitätsmedizin Berlin
🇩🇪Berlin, Germany
BG-Unfallklinik Ludwigshafen
🇩🇪Ludwigshafen, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Hospital Universitario Son Llàtzer
🇪🇸Palma De Mallorca, Spain
Universitätsspital Basel
🇨🇭Basel, Switzerland
Kantonspital Baselland
🇨🇭Liestal, Switzerland
Universitätsspital Zürich
🇨🇭Zürich, Switzerland
University of Missouri Health Care
🇺🇸Columbia, Missouri, United States
Jersey City Medical Center RWJ Barnabas Health
🇺🇸Jersey City, New Jersey, United States
Saint Barnabas Medical Center Livingston
🇺🇸Livingston, New Jersey, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Universitaire Ziekenhuiven Leuven
🇧🇪Leuven, Belgium
Hospital Santa Clara
🇨🇴Bogotá, Colombia