Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 10:55 PM
Study NCT ID:
NCT06699134
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hi-Fatigue G Bone Cement Retrospective Study
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
Evaluation of Hi-Fatigue G Bone Cement With Gentamicin A Retrospective Data Collection
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: