Actively Recruiting
Hi-Fatigue G Bone Cement Retrospective Study
Led by Zimmer Biomet · Updated on 2025-12-02
90
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Hi-Fatigue G Bone Cement Retrospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject qualified for cemented total knee arthroplasty (TKA) or total hip arthroplasty (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 is older than 18 years
You will not qualify if you...
- 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 person (prisoner, mentally incompetent, unable to understand participation, known alcohol or drug abuser, or expected to be non-compliant)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Klinikum Weiden
Weiden, Bavaria, Germany, 92637
Actively Recruiting
Research Team
M
Miguel Correa-Tapia
CONTACT
L
Linda Meijer
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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