Periprosthetic Fracture Registry (PPFx) (PPFx)

Multicenter Prospective Registry for Periprosthetic Fractures After Hip or Knee Arthroplasty

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.

Study Overview

• Status: Recruiting
• Conditions: Periprosthetic Fractures; Periprosthetic Fracture Around Prosthetic Joint Implant

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

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Viola Grünenfelder; Phone Number: +41 796963397; Email: Viola.Gruenenfelder@aofoundation.org
• Study Contact Backup: Name: Marco Minoia; Phone Number: +41 79 612 09 67; Email: marco.minoia@aofoundation.org

Study Locations

• Belgium
  • Leuven, Belgium
    • Recruiting
    • Universitaire Ziekenhuiven Leuven
    • Contact: An Sermon; Phone Number: +32 16 34 45 92; Email: an.sermon@uzleuven.be
• Colombia
  • Bogotá, Colombia
    • Recruiting
    • Hospital Santa Clara
    • Contact: Saúl Leonardo Martínez Prieto, MD; Phone Number: 573105616266; Email: smart7406@yahoo.com
• Germany
  • Berlin, Germany
    • Recruiting
    • Charité Universitätsmedizin Berlin
    • Contact: Marcel Niemann, MD; Email: marcel.niemann@charite.de
  • Ludwigshafen, Germany
    • Recruiting
    • BG-Unfallklinik Ludwigshafen
    • Contact: Paul Grützner, MD; Phone Number: +49 62168102311; Email: Paul.Gruetzner@bgu-ludwigshafen.de
  • Münster, Germany
    • Recruiting
    • Universitatsklinikum Munster
    • Contact: Michael J. Raschke, MD; Phone Number: +49 251 4841 881; Email: Michael.Raschke@uni-muenster.de
• Spain
  • Palma de Mallorca, Spain
    • Recruiting
    • Hospital Universitario Son Llatzer
    • Contact: Angel Del Rio Mangada, MD; Email: ario@hsll.es
• Switzerland
  • Basel, Switzerland
    • Recruiting
    • Universitätsspital Basel
    • Contact: Dominik Bühler, Dr. med.; Email: Dominik.Buehler@usb.ch
  • Liestal, Switzerland, 4410
    • Terminated
    • Kantonspital Baselland
  • Zurich, Switzerland
    • Recruiting
    • UniversitätsSpital Zürich
    • Contact: Hans-Christoph Pape, MD; Email: hans-christoph.pape@usz.ch
• United States
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Recruiting
      • University of Missouri Health Care
      • Contact: Gregory Della Rocca, MD; Email: dellaroccag@health.missouri.edu
  • New Jersey
    • Jersey City, New Jersey, United States, 07302
      • Recruiting
      • Jersey City Medical Center RWJ Barnabas Health
      • Contact: Frank A. Liporace, MD; Phone Number: 2017165854; Email: liporace33@gmail.com
    • Livingston, New Jersey, United States, 07039
      • Recruiting
      • Saint Barnabas Medical Center Livingston
      • Contact: Richard S. Yoon, MD; Phone Number: 2017165847; Email: yoonrich@gmail.com
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: William Obremskey, MD; Email: william.obremskey@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Classification of the fracture	Classification of the fracture using the UCS and some parts of the AO/OTA fracture classification system.	Pre-operatively (Day -1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fracture mechanism	High / low energy trauma, pathological fracture, stem stability	Pre-operatively (Day -1)
Rehabilitation program	weight bearing, bedrest, splint	Up to 12 months
Function of hip or knee	Harris Hip Score or Knee Society score	Up to 12 months
Health related quality of life	PROMIS pain interference and physical activity	Up to 12 months
Fracture healing	by RUSH or RUST score	Up to 12 months
pain visual analog scale (VAS) and pain medication	Using the pain visual analog scale (VAS) and pain medication	Up to 12 months

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Investigators: Principal Investigator: Karl Stoffel, MD, Universitätsspital Basel

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2018
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Periprosthetic Fractures
• Other Study ID Numbers: PPFx

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No