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

Status: Recruiting
Location: See location...
Intervention Type: Device
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 should be specified. * Evaluation of PROMs * Obtain information regarding the cementing technique and handling of the cement, if available

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Klinikum Weiden
RECRUITING
Weiden
Contact Information
Primary
Chiara Griffoni
chiara.griffoni@zimmerbiomet.com
+41795601628
Backup
Sabine Illi
sabine.illi@zimmerbiomet.com
+41792014430
Time Frame
Start Date: 2024-11-19
Estimated Completion Date: 2026-10
Participants
Target number of participants: 90
Treatments
Patients with TKA
Patients with primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
Patients with THA
Patients with primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
Related Therapeutic Areas
Sponsors
Leads: Zimmer Biomet

This content was sourced from clinicaltrials.gov