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RecruitingNCT03378557PPFxUpdated Sep 12, 2025

Periprosthetic Fracture Registry (PPFx)

An observational study in Periprosthetic Fractures and Periprosthetic Fracture Around Prosthetic Joint Implant, sponsored by AO Innovation Translation Center. Recruiting at 13 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by AO Innovation Translation Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Periprosthetic Fractures
  • Periprosthetic Fracture Around Prosthetic Joint Implant
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with total or hemi hip or knee arthroplasty and who have a fracture around one of the arthroplasty

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

Exclusion Criteria:

  • Pregnancy or women planning to conceive within the study period
  • Prisoner
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
600 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. Classification of the fracture

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

    Time frame: Pre-operatively (Day -1)

Secondary outcomes

  1. Fracture mechanism

    High / low energy trauma, pathological fracture, stem stability

    Time frame: Pre-operatively (Day -1)

  2. Rehabilitation program

    weight bearing, bedrest, splint

    Time frame: Up to 12 months

  3. Function of hip or knee

    Harris Hip Score or Knee Society score

    Time frame: Up to 12 months

  4. Health related quality of life

    PROMIS pain interference and physical activity

    Time frame: Up to 12 months

  5. Fracture healing

    by RUSH or RUST score

    Time frame: Up to 12 months

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

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

    Time frame: Up to 12 months

06

Study locations

12 of 13 sites recruiting
  • University of Missouri Health Care
    Columbia, Missouri 65201, United States
    Recruiting
  • Jersey City Medical Center RWJ Barnabas Health
    Jersey City, New Jersey 07302, United States
    Recruiting
  • Saint Barnabas Medical Center Livingston
    Livingston, New Jersey 07039, United States
    Recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
    Recruiting
  • Universitaire Ziekenhuiven Leuven
    Leuven, Belgium
    Recruiting
  • Hospital Santa Clara
    Bogotá, Colombia
    Recruiting
  • Charité Universitätsmedizin Berlin
    Berlin, Germany
    Recruiting
  • BG-Unfallklinik Ludwigshafen
    Ludwigshafen, Germany
    Recruiting
  • Universitätsklinikum Münster
    Münster, Germany
    Recruiting
  • Hospital Universitario Son Llàtzer
    Palma de Mallorca, Spain
    Recruiting
  • Universitätsspital Basel
    Basel, Switzerland
    Recruiting
  • Kantonspital Baselland
    Liestal, 4410, Switzerland
    Terminated
  • Universitätsspital Zürich
    Zurich, Switzerland
    Recruiting
07

References and documents

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. PubMed 39110721 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03378557
Lead sponsor
AO Innovation Translation Center
Responsible party
Sponsor
First posted
Dec 20, 2017
Start date
Dec 31, 2018
Primary completion
Jan 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Sep 12, 2025

Study contacts

Marco Minoia
Contact
marco.minoia@aofoundation.org
+41 79 612 09 67
Viola Grünenfelder
Contact
Viola.Gruenenfelder@aofoundation.org
+41 796963397
Karl Stoffel, MD
principal investigator · Universitätsspital Basel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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