Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06699134

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 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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Total Hip and Knee Arthroplasties

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Total knee arthroplasty

Device

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

Total hip arthroplasty

Device

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Linda Meijer

CONTACT

[email protected]

+31657933741

Miguel Correa-Tapia

CONTACT

[email protected]

+41791522905

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2024
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.