NCT03378557

Brief 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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
6 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Dec 2018Mar 2027

First Submitted

Initial submission to the registry

November 14, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

December 31, 2018

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

8.1 years

First QC Date

November 14, 2017

Last Update Submit

September 8, 2025

Conditions

Periprosthetic FracturesPeriprosthetic Fracture Around Prosthetic Joint Implant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Fracture mechanism

    Pre-operatively (Day -1)

  • Rehabilitation program

    Up to 12 months

  • Function of hip or knee

    Up to 12 months

  • Health related quality of life

    Up to 12 months

  • Fracture healing

    Up to 12 months

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

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

Related Publications (1)

  • 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.

    PMID: 39110721DERIVED

MeSH Terms

Conditions

Periprosthetic Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • Karl Stoffel, MD

    Universitätsspital Basel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Minoia

CONTACT

+41 79 612 09 67marco.minoia@aofoundation.org

Viola Grünenfelder

CONTACT

+41 796963397Viola.Gruenenfelder@aofoundation.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2017

First Posted

December 20, 2017

Study Start

December 31, 2018

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CH(3)ES(1)US(4)BE(1)CO(1)DE(3)