Evaluating Hi-Fatigue G Bone Cement in Hip and Knee Replacements

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect and analyze data on the safety and performance of Hi-Fatigue G Bone Cement used in total hip and knee arthroplasties. It will involve a retrospective review of clinical outcomes, including radiological assessments and patient-reported outcomes over a five-year period. The study will monitor implant survivorship and any adverse events related to the cement and surgical procedures. Data will be gathered from patients who have undergone cemented procedures with Zimmer Biomet implants.

Why it matters

Who can join: the full rules

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)

Where it's running

• Klinikum Weiden
  Weiden, Bavaria, Germany Recruiting

Study contacts

• Study coordinator: Miguel Correa-Tapia
• Email: Miguel.CorreaTapia@zimmerbiomet.com
• Phone: +41791522905

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.