Overview
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
Inclusion Criteria:
- 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
Exclusion Criteria:
- Muscle wasting
- Neuromuscular compromise in the affected limb
- Known hypersensitivity to any of the cement constituents
- Subjects with severe renal failure
- Bilateral interventions
- Subject is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, known alcohol or drug abuser, anticipated to be non-compliant)