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Hi-Fatigue G Bone Cement Retrospective Study

NCT06699134 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2025-12-02

No results posted yet for this study

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

Conditions

  • Total Hip and Knee Arthroplasties

Interventions

DEVICE

Total knee arthroplasty

Primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant

DEVICE

Total Hip arthroplasty

Primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-19
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06699134 on ClinicalTrials.gov