Hi-Fatigue G Bone Cement Retrospective Study

December 1, 2025 updated by: Zimmer Biomet

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Bavaria
      • Weiden, Bavaria, Germany, 92637

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients operated with primary total knee or hip replacement using Hi-Fatigue G Bone Cement, a Zimmer Biomet implant, and who meet the inclusion / exclusion criteria for study participation.

Two consecutive groups of patients that underwent cemented TKA or THA according to the instructions for use of both the respective implant and of Hi-Fatigue G Bone Cement.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with TKA
Patients with primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
Device: Total knee arthroplasty
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
Device: Total Hip arthroplasty
Primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic evaluation
Time Frame: From enrollment to the 5 year post-op follow up.
Detection of radiolucent lines around the implant components (tibial, femoral, acetabular) at 5 years (in accordance with the hospital standard of care).
From enrollment to the 5 year post-op follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cement Information
Time Frame: From enrollment to the 5 year post-op follow up.
Obtain information regarding the cementing technique and handling of the cement, if available
From enrollment to the 5 year post-op follow up.
Survivorship
Time Frame: From enrollment to the 5 year post-op follow up.
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.
From enrollment to the 5 year post-op follow up.
Patient reported outcome measures (PROM)
Time Frame: From enrollment to the 5 year post-op follow up.
Evaluation of PROMs, collected in accordance with the hospital standard of care.
From enrollment to the 5 year post-op follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 21, 2024

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CME2020-38C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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