Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
90 participants
OBSERVATIONAL
2024-11-19
2026-10-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients with TKA
Patients with primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
Total knee arthroplasty
Primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
Patients with THA
Patients with primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
Total Hip arthroplasty
Primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
Interventions
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Total knee arthroplasty
Primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
Total Hip arthroplasty
Primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Locations
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Klinikum Weiden
Weiden, Bavaria, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CME2020-38C
Identifier Type: -
Identifier Source: org_study_id
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