Recruiting

Observational Study

Sponsor:

AO Innovation Translation Center

Code:

NCT03378557

Conditions

Periprosthetic Fractures

Periprosthetic Fracture Around Prosthetic Joint Implant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Periprosthetic Fractures

Periprosthetic Fracture Around Prosthetic Joint Implant

Study ID

NCT03378557

Start date

Dec 31, 2018

Status verified date

Sep, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Classification of the fracture [ Time Frame: Pre-operatively (Day -1) ]

Central Contacts and Locations

Locations

University of Missouri Health Care

Recruiting

Columbia, Missouri, United States, 65201

Contacts

Gregory Della Rocca, MD

dellaroccag@health.missouri.edu

Jersey City Medical Center RWJ Barnabas Health

Recruiting

Jersey City, New Jersey, United States, 07302

Contacts

Frank A. Liporace, MD

2017165854liporace33@gmail.com

Saint Barnabas Medical Center Livingston

Recruiting

Livingston, New Jersey, United States, 07039

Contacts

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

William Obremskey, MD

William.Obremskey@vumc.org

More Information

Sponsor

AO Innovation Translation Center

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AO Innovation Translation Center on 2025-09-12.