Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
NCT07653295
Aseptic Loosening of Prosthetic Joint, Fractures, Bone
Balıkesir, Turkey (Türkiye)
View Trial DetailsNCT Number: NCT03378557
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Universitaire Ziekenhuiven Leuven, Leuven, Belgium
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Pre-operatively (Day -1)
Classification of the fracture using the UCS and some parts of the AO/OTA fracture classification system.
Time frame: Pre-operatively (Day -1)
High / low energy trauma, pathological fracture, stem stability
Time frame: Up to 12 months
weight bearing, bedrest, splint
Time frame: Up to 12 months
Harris Hip Score or Knee Society score
Time frame: Up to 12 months
PROMIS pain interference and physical activity
Time frame: Up to 12 months
by RUSH or RUST score
Time frame: Up to 12 months
Using the pain visual analog scale (VAS) and pain medication
Contact information is provided by the study sponsor or research team.
Marco Minoia
CONTACT
Viola Grünenfelder
CONTACT
AO Innovation Translation Center
Other
Multicenter Prospective Registry for Periprosthetic Fractures After Hip or Knee Arthroplasty
Acronym: PPFx
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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