Periprosthetic Fracture Registry (PPFx)

Periprosthetic Fractures Clinical Trial

— PPFx  

Official title:

Multicenter Prospective Registry for Periprosthetic Fractures After Hip or Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03378557
• Other study ID #: PPFx
• Status: Recruiting
• Start date: December 31, 2018
• Est. completion date: March 31, 2027

Study information

• Verified date: March 2024
• Source: AO Innovation Translation Center
• Contact: Cynthia Sob
• Phone: +41 79 893 74 28
• Email: cynthia.sob[@]aofoundation.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Periprosthetic Fracture Around Prosthetic Joint Implant
• Periprosthetic Fractures

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuiven Leuven	Leuven
Colombia	Hospital Santa Clara	Bogotá
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	BG-Unfallklinik Ludwigshafen	Ludwigshafen
Germany	Universitätsklinikum Münster	Münster
Spain	Hospital Universitario Son Llàtzer	Palma De Mallorca
Switzerland	Universitätsspital Basel	Basel
Switzerland	Kantonspital Baselland	Liestal
Switzerland	Universitätsspital Zürich	Zürich
United States	University of Missouri Health Care	Columbia	Missouri
United States	Jersey City Medical Center RWJ Barnabas Health	Jersey City	New Jersey
United States	Saint Barnabas Medical Center Livingston	Livingston	New Jersey
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
AO Innovation Translation Center

Countries where clinical trial is conducted

United States,  Belgium,  Colombia,  Germany,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fracture mechanism	High / low energy trauma, pathological fracture, stem stability	Pre-operatively (Day -1)
Secondary	Rehabilitation program	weight bearing, bedrest, splint	Up to 12 months
Secondary	Function of hip or knee	Harris Hip Score or Knee Society score	Up to 12 months
Secondary	Health related quality of life	PROMIS pain interference and physical activity	Up to 12 months
Secondary	Fracture healing	by RUSH or RUST score	Up to 12 months
Secondary	pain visual analog scale (VAS) and pain medication	Using the pain visual analog scale (VAS) and pain medication	Up to 12 months