Hi-Fatigue G Bone Cement Retrospective Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total knee arthroplasty, Total Hip arthroplasty.
- Who it may be relevant to
- Registry conditions: Total Hip and Knee Arthroplasties. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Hi-Fatigue G Bone Cement With Gentamicin A Retrospective Data Collection
Overview
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
Interventions
- Device Total knee arthroplasty
Primary total knee 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
Primary outcome measures
- Radiographic evaluation [Time frame: From enrollment to the 5 year post-op follow up.]
Secondary outcome measures (3)
- Survivorship [Time frame: 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.]
- Cement Information [Time frame: From enrollment to the 5 year post-op follow up.]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Klinikum Weiden — Weiden
Identifiers
NCT: NCT06699134 · CME2020-38C