Periprosthetic Fracture Registry (PPFx)

AO Innovation Translation Center

Status: Enrolling

Conditions: Periprosthetic Fractures; Periprosthetic Fracture Around Prosthetic Joint Implant

Study type: Observational

Funder types: Other

Identifiers

NCT03378557

PPFx

Details and patient eligibility

About

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.

Full 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

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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