Periprosthetic Fracture Around Prosthetic Joint Implant, Periprosthetic Fractures
Conditions
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
Interventions
None listed
Sponsors
AO Innovation Translation Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rehabilitation program | Up to 12 months | weight bearing, bedrest, splint |
| Function of hip or knee | Up to 12 months | Harris Hip Score or Knee Society score |
| Fracture mechanism | Pre-operatively (Day -1) | High / low energy trauma, pathological fracture, stem stability |
| 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 |
| Health related quality of life | Up to 12 months | PROMIS pain interference and physical activity |
Countries
Belgium, Colombia, Germany, Spain, Switzerland, United States
Contacts
Primary ContactMarco Minoia
Backup ContactViola Grünenfelder
Outcome results
None listed