Hi-Fatigue G Bone Cement Retrospective Study
ConditionTotal Hip and Knee Arthroplasties
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZimmer Biomet
About this trial
The objective of this retrospective monocentric study is to collect survivorship and clinical data confirming safety, performance and clinical benefits for the Hi-Fatigue G Bone Cement.
The assessments will include:
* Radiological analysis performed at different time points according to the standard of care of the hospital * Implant survivorship and safety based on removal of a study device * Patient reported outcome measures (PROMs)
Primary endpoint:
Assessment of radiolucent lines around the components (tibial, femoral, acetabular) at 5 years (in accordance with the hospital standard of care).
Secondary endpoints:
* Evaluation of implant survivorship and safety by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. * Evaluation of PROMs * Obtain information regarding the cementing technique and handling of the cement, if available
Eligibility criteria
Qualifiers
Subject qualified for cemented TKA or THA with a Zimmer Biomet implant
Subject is willing and able to give written informed consent for retrospective data collection and undergo interim and final evaluation (X-Ray & Scores completion)
Subject > 18 years old
Disqualifiers
Muscle wasting
Neuromuscular compromise in the affected limb
Known hypersensitivity to any of the cement constituents
Subjects with severe renal failure
Trial design
Treatments tested in this trial
- Total knee arthroplasty
- Total Hip arthroplasty
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov