Periprosthetic Fracture Registry (PPFx)

NCT ID: NCT03378557

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-31

Study Completion Date

2027-03-31

Brief Summary

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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

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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

Conditions

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Periprosthetic Fractures Periprosthetic Fracture Around Prosthetic Joint Implant

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AO Innovation Translation Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karl Stoffel, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsspital Basel

Locations

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University of Missouri Health Care

Columbia, Missouri, United States

Site Status RECRUITING

Jersey City Medical Center RWJ Barnabas Health

Jersey City, New Jersey, United States

Site Status RECRUITING

Saint Barnabas Medical Center Livingston

Livingston, New Jersey, United States

Site Status RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

Universitaire Ziekenhuiven Leuven

Leuven, , Belgium

Site Status RECRUITING

Hospital Santa Clara

Bogotá, , Colombia

Site Status RECRUITING

Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status RECRUITING

BG-Unfallklinik Ludwigshafen

Ludwigshafen, , Germany

Site Status RECRUITING

Universitätsklinikum Münster

Münster, , Germany

Site Status RECRUITING

Hospital Universitario Son Llàtzer

Palma de Mallorca, , Spain

Site Status RECRUITING

Universitätsspital Basel

Basel, , Switzerland

Site Status RECRUITING

Kantonspital Baselland

Liestal, , Switzerland

Site Status TERMINATED

Universitätsspital Zürich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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United States Belgium Colombia Germany Spain Switzerland

Central Contacts

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Marco Minoia

Role: CONTACT

+41 79 612 09 67

Viola Grünenfelder

Role: CONTACT

+41 796963397

Facility Contacts

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Gregory Della Rocca, MD

Role: primary

Frank A. Liporace, MD

Role: primary

2017165854

Richard S. Yoon, MD

Role: primary

2017165847

William Obremskey, MD

Role: primary

An Sermon

Role: primary

+32 16 34 45 92

Saúl Leonardo Martínez Prieto, MD

Role: primary

573105616266

Marcel Niemann, MD

Role: primary

Paul Grützner, MD

Role: primary

+49 62168102311

Michael J. Raschke, MD

Role: primary

+49 251 4841 881

Angel Del Rio Mangada, MD

Role: primary

Dominik Bühler, Dr. med.

Role: primary

Hans-Christoph Pape, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 39110721 (View on PubMed)

Other Identifiers

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PPFx

Identifier Type: -

Identifier Source: org_study_id

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