Registry for collecting data on periprosthetic fractures after hip and knee surgeries
Multicenter Prospective Registry for Periprosthetic Fractures After Hip or Knee Arthroplasty
This study is collecting information on how different treatments for fractures around hip and knee implants affect recovery to help improve care for patients who experience these injuries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AO Innovation Translation Center Academic / other |
| Locations | 13 sites (Columbia, Missouri and 12 other locations) |
| Trial ID | NCT03378557 on ClinicalTrials.gov |
What this trial studies
This registry aims to gather international data on the treatment of periprosthetic fractures (PPFx) following hip and knee arthroplasty. It focuses on understanding the influence of various factors such as implant types, surgical techniques, and rehabilitation programs on patient outcomes. By identifying risk factors for failure and comparing outcomes across different treatment approaches, the registry seeks to fill gaps in clinical evidence and improve future orthopedic practices. The data collected will support further research and enhance medical decision-making in the treatment of PPFx.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have experienced a periprosthetic fracture after hip or knee arthroplasty requiring surgical intervention.
Not a fit: Patients who are pregnant or planning to conceive during the study period, as well as prisoners, may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could lead to improved treatment strategies and better outcomes for patients with periprosthetic fractures.
How similar studies have performed: While this registry approach is not novel, it builds on previous efforts to collect data on orthopedic outcomes, which have shown promise in improving patient care.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Columbia, Missouri and 12 other locations
- University of Missouri Health Care — Columbia, Missouri, United States (Recruiting)
- Jersey City Medical Center RWJ Barnabas Health — Jersey City, New Jersey, United States (Recruiting)
- Saint Barnabas Medical Center Livingston — Livingston, New Jersey, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, 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, Switzerland (Terminated)
- Universitätsspital Zürich — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Karl Stoffel, MD — Universitätsspital Basel
- Study coordinator: Marco Minoia
- Email: marco.minoia@aofoundation.org
- Phone: +41 79 612 09 67
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.