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NCT Number: NCT03378557

Periprosthetic Fracture Registry (PPFx)

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaire Ziekenhuiven Leuven, Leuven, Belgium

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About this study

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:

  • Influence of implants on outcome
  • Influence of surgical techniques on outcome
  • Influence of bone grafting on outcome
  • Identification of risk factors for failure
  • Identification of postoperative rehabilitation programs and its possible influence on the outcome
  • Influence of fracture type on outcome
  • To serve as a comparative dataset for future studies with improved implants and techniques

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Classification of the fracture

    Time frame: Pre-operatively (Day -1)

    Classification of the fracture using the UCS and some parts of the AO/OTA fracture classification system.

Secondary outcomes

  1. Fracture mechanism

    Time frame: Pre-operatively (Day -1)

    High / low energy trauma, pathological fracture, stem stability

  2. Rehabilitation program

    Time frame: Up to 12 months

    weight bearing, bedrest, splint

  3. Function of hip or knee

    Time frame: Up to 12 months

    Harris Hip Score or Knee Society score

  4. Health related quality of life

    Time frame: Up to 12 months

    PROMIS pain interference and physical activity

  5. Fracture healing

    Time frame: Up to 12 months

    by RUSH or RUST score

  6. pain visual analog scale (VAS) and pain medication

    Time frame: Up to 12 months

    Using the pain visual analog scale (VAS) and pain medication

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Minoia

CONTACT

[email protected]

+41 79 612 09 67

Viola Grünenfelder

CONTACT

[email protected]

+41 796963397

Sponsors and collaborators

Lead sponsor

AO Innovation Translation Center

Other

Registry information

Official study title

Multicenter Prospective Registry for Periprosthetic Fractures After Hip or Knee Arthroplasty

Acronym: PPFx

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Dec 20, 2017
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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