Periprosthetic Fracture Registry (PPFx)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Periprosthetic Fractures, Periprosthetic Fracture Around Prosthetic Joint Implant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, Colombia, Germany, Spain +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicenter Prospective Registry for Periprosthetic Fractures After Hip or Knee Arthroplasty
Overview
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
Primary outcome measures
- Classification of the fracture [Time frame: Pre-operatively (Day -1)]
Secondary outcome measures (6)
- Fracture mechanism [Time frame: Pre-operatively (Day -1)]
- Rehabilitation program [Time frame: Up to 12 months]
- Function of hip or knee [Time frame: Up to 12 months]
- Health related quality of life [Time frame: Up to 12 months]
- Fracture healing [Time frame: Up to 12 months]
- pain visual analog scale (VAS) and pain medication [Time frame: Up to 12 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Pregnancy or women planning to conceive within the study period
- Prisoner
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 4 centers
- University of Missouri Health Care — Columbia
- Jersey City Medical Center RWJ Barnabas Health — Jersey City
- Saint Barnabas Medical Center Livingston — Livingston
- Vanderbilt University Medical Center — Nashville
Germany · 3 centers
- Charité Universitätsmedizin Berlin — Berlin
- BG-Unfallklinik Ludwigshafen — Ludwigshafen
- Universitätsklinikum Münster — Münster
Switzerland · 3 centers
- Universitätsspital Basel — Basel
- Kantonspital Baselland — Liestal
- Universitätsspital Zürich — Zurich
Belgium · 1 center
- Universitaire Ziekenhuiven Leuven — Leuven
Colombia · 1 center
- Hospital Santa Clara — Bogotá
Spain · 1 center
- Hospital Universitario Son Llàtzer — Palma de Mallorca
Publications
- Uzoigwe CE, Watts AT, Briggs P, Symes T. Periprosthetic Femoral Fractures-Beyond B2. J Am Acad Orthop Surg Glob Res Rev. 2024 Aug 6;8(8):e23.00135. doi: 10.5435/JAAOSGlobal-D-23-00135. eCollection 2024 Aug 1. PMID 39110721
Identifiers
NCT: NCT03378557 · PPFx