Evaluating Hi-Fatigue G Bone Cement in Hip and Knee Replacements
Evaluation of Hi-Fatigue G Bone Cement With Gentamicin A Retrospective Data Collection
This study looks at how safe and effective a special type of bone cement is for people who have had hip or knee replacement surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zimmer Biomet Industry-sponsored |
| Locations | 1 site (Weiden, Bavaria) |
| Trial ID | NCT06699134 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are undergoing cemented total knee or hip arthroplasty with a Zimmer Biomet implant.
Not a fit: Patients with muscle wasting, neuromuscular compromise, severe renal failure, or known hypersensitivity to cement constituents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the safety and effectiveness of Hi-Fatigue G Bone Cement, potentially leading to improved outcomes for patients undergoing hip and knee replacements.
How similar studies have performed: While this study focuses on a specific type of bone cement, similar studies evaluating different cements have shown promising results in improving implant survivorship and patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Weiden, Bavaria
- Klinikum Weiden — Weiden, Bavaria, Germany (Recruiting)
Study contacts
- Study coordinator: Miguel Correa-Tapia
- Email: Miguel.CorreaTapia@zimmerbiomet.com
- Phone: +41791522905
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.