Clinical trial NCT03378557: Periprosthetic Fracture Registry (PPFx)
Official title: Multicenter Prospective Registry for Periprosthetic Fractures After Hip or Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Periprosthetic Fractures
Periprosthetic Fracture Around Prosthetic Joint Implant
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with total or hemi hip or knee arthroplasty and who have a fracture around one of the arthroplasty

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.

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:

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

Eligibility 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

Primary outcomes:
measure: Classification of the fracture
timeFrame: Pre-operatively (Day -1)
Secondary outcomes:
measure: Fracture mechanism
timeFrame: Pre-operatively (Day -1)
measure: Rehabilitation program
timeFrame: Up to 12 months
measure: Function of hip or knee
timeFrame: Up to 12 months
measure: Health related quality of life
timeFrame: Up to 12 months
measure: Fracture healing
timeFrame: Up to 12 months
measure: pain visual analog scale (VAS) and pain medication
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Jersey City
country: United States
facility: Jersey City Medical Center RWJ Barnabas Health
state: New Jersey
city: Livingston
country: United States
facility: Saint Barnabas Medical Center Livingston
state: New Jersey
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuiven Leuven
city: Bogotá
country: Colombia
facility: Hospital Santa Clara
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Ludwigshafen
country: Germany
facility: BG-Unfallklinik Ludwigshafen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Llàtzer
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Liestal
country: Switzerland
facility: Kantonspital Baselland
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Universitätsspital Basel
name: Karl Stoffel, MD
role: PRINCIPAL_INVESTIGATOR
References: