Hi-Fatigue G Bone Cement Retrospective Study

Evaluation of Hi-Fatigue G Bone Cement With Gentamicin A Retrospective Data Collection

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

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)