Hi-Fatigue G Bone Cement Retrospective Study
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 hosp
| Condition(s) | Total Hip and Knee Arthroplasties |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 |
| Who can participate | 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) |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Zimmer Biomet |
| Locations | Weiden, Bavaria, Germany |
| Start date | 2024-11-19 |
| NCT ID | NCT06699134 |
| Official listing | https://clinicaltrials.gov/study/NCT06699134 |