Combined Prospective and Retrospective Post-Market Follow Up of the 'BPK-S Integration' UC as Primary Implant in the Variant CoCr
NCT ID: NCT03406637
Last Updated: 2020-03-06
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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COMPLETED
62 participants
OBSERVATIONAL
2018-10-17
2020-03-02
Brief Summary
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Only patients providing written informed consent prior to any study data collection can take part in the study.
Preoperative, intraoperative and early postoperative data (3 months, 1 year and 2 years after implantation) will be collected retrospectively. Additional long-term follow-up of one visit (year 7 after implantation) will be documented prospectively.
Only parameters assessed in clinical standard care for follow-up (implant control) visits will be collected for this PMCF study.
Radiological assessment of the implanted prosthesis will only be conducted if medically indicated according to the investigator. No additional study related assessment will be performed.
Only anonymized data will be used in this observational study to protect patient privacy. No personally identifiable information will be collected.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
OTHER
Interventions
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BPK-S Integration
primary total knee endoprosthesis
Eligibility Criteria
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Inclusion Criteria
* Patients that agree to participate and give written informed consent to the anonymized retrospective and prospective data collection within the study
18 Years
ALL
No
Sponsors
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P.R.I.S.M.A.-CRO
UNKNOWN
Peter Brehm GmbH
INDUSTRY
Responsible Party
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Locations
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Centre Hospitalier de Wallonie picarde - CHwapi A.S.B.L
Tournai, , Belgium
Medical Center Tournai
Tournai, , Belgium
Countries
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Other Identifiers
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2016-01-BPK-S
Identifier Type: -
Identifier Source: org_study_id
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