Periprosthetic FracturesPPFxNCT03378557
Periprosthetic Fracture Registry (PPFx)
An observational study of Periprosthetic Fractures and Periprosthetic Fracture Around Prosthetic Joint Implant, run by AO Innovation Translation Center at 13 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Fractures, Periprosthetic Fracture Around Prosthetic Joint Implant
- How many people
- 600 participants
- Where
- 13 sitesin 6 countries
- Study dates
- 31 Dec 2018to 31 Mar 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with total or hemi hip or knee arthroplasty and who have a fracture around one of the arthroplasty
Who may be able to join
- 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
Who cannot join
- Pregnancy or women planning to conceive within the study period
- Prisoner
Trial locations and contacts
13 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 6 countries
United States4 sites, 4 recruiting
- Recruiting
University of Missouri Health Care
Columbia, Missouri, 65201
Gregory Della Rocca, MD, dellaroccag@health.missouri.edu
- Recruiting
Jersey City Medical Center RWJ Barnabas Health
Jersey City, New Jersey, 07302
Frank A. Liporace, MD, 2017165854, liporace33@gmail.com
- Recruiting
Saint Barnabas Medical Center Livingston
Livingston, New Jersey, 07039
Richard S. Yoon, MD, 2017165847, yoonrich@gmail.com
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
William Obremskey, MD, William.Obremskey@vumc.org
Germany3 sites, 3 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin
Marcel Niemann, MD, marcel.niemann@charite.de
- Recruiting
BG-Unfallklinik Ludwigshafen
Ludwigshafen
Paul Grützner, MD, +49 62168102311, Paul.Gruetzner@bgu-ludwigshafen.de
- Recruiting
Universitätsklinikum Münster
Münster
Michael J. Raschke, MD, +49 251 4841 881, Michael.Raschke@uni-muenster.de
Switzerland3 sites, 2 recruiting
- Recruiting
Universitätsspital Basel
Basel
Dominik Bühler, Dr. med., Dominik.Buehler@usb.ch
- Terminated
Kantonspital Baselland
Liestal, 4410
- Recruiting
Universitätsspital Zürich
Zurich
Hans-Christoph Pape, MD, hans-christoph.pape@usz.ch
Belgium1 site, 1 recruiting
- Recruiting
Universitaire Ziekenhuiven Leuven
Leuven
An Sermon, +32 16 34 45 92, an.sermon@uzleuven.be
Colombia1 site, 1 recruiting
- Recruiting
Hospital Santa Clara
Bogotá
Saúl Leonardo Martínez Prieto, MD, 573105616266, smart7406@yahoo.com
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Son Llàtzer
Palma de Mallorca
Angel Del Rio Mangada, MD, ario@hsll.es
About this study
Official title: 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.
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:
- 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
- Medical subject headings
- Periprosthetic Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification of the fracture
Classification of the fracture using the UCS and some parts of the AO/OTA fracture classification system.
Measured: Pre-operatively (Day -1)
Secondary outcomes (6)
Fracture mechanism
High / low energy trauma, pathological fracture, stem stability
Measured: Pre-operatively (Day -1)
Rehabilitation program
weight bearing, bedrest, splint
Measured: Up to 12 months
Function of hip or knee
Harris Hip Score or Knee Society score
Measured: Up to 12 months
Health related quality of life
PROMIS pain interference and physical activity
Measured: Up to 12 months
Fracture healing
by RUSH or RUST score
Measured: Up to 12 months
pain visual analog scale (VAS) and pain medication
Using the pain visual analog scale (VAS) and pain medication
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start31 Dec 2018
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periprosthetic FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karl Stoffel, MD, Principal investigator, Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378557
- Sponsor's protocol ID
- PPFx
- Acronym
- PPFx
- Status last verified
- Sep 2025
- First submitted
- 14 Nov 2017
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Registry for Periprosthetic Fractures After Hip or Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03378557
- Acronym / sponsor ID
- PPFx / PPFx
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with total or hemi hip or knee arthroplasty and who have a fracture around one of the arthroplasty
Key inclusion criteria (8 listed)
- Age ≥18 years
Key exclusion criteria (2 listed)
- Pregnancy or women planning to conceive within the study period
- Prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Fracture mechanism
Time frame: Pre-operatively (Day -1)
Rehabilitation program
Time frame: Up to 12 months
Function of hip or knee
Time frame: Up to 12 months
Health related quality of life
Time frame: Up to 12 months
Fracture healing
Time frame: Up to 12 months
pain visual analog scale (VAS) and pain medication
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Derived from this study: PubMed 39110721Uzoigwe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karl Stoffel, MD principal investigator
Universitätsspital Basel
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periprosthetic Fractures and Periprosthetic Fracture Around Prosthetic Joint Implant, run by AO Innovation Translation Center at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Germany, Switzerland, Belgium, Colombia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Minoia (+41 79 612 09 67, marco.minoia@aofoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification of the fracture (time frame: Pre-operatively (Day -1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03378557, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.