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
43 participants
OBSERVATIONAL
2022-01-19
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Revision Total Knee Arthroplasty
Total Knee Arthroplasty in case of failure of a previous operation.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years old
* Given written informed consent approved by the reference Ethics Committee (EC)
* Subjects in whom a decision has already been made to perform a Total Knee Arthroplasty with the Multigen Plus H system as per Indication For Use. The decision to implant a Multigen Plus H system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to enrol the subject. This decision should be made in accordance with routine clinical practice at the study site concerned.
* Subject is able to comply with the protocol
Exclusion Criteria
* Subjects with any Multigen Plus system contraindication for use, or any AMF TT cones contraindication for use when used in combination with the Multigen Plus H, as reported in the current Instruction For Use.
* Any clinically significant pathology based on the medical history or any medical intervention that the Investigator feels may affect the study evaluation
* Female subjects who are pregnant, nursing, or planning a pregnancy
* Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS \< 70 points.
18 Years
ALL
No
Sponsors
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North American Science Associates Ltd.
NETWORK
Limacorporate S.p.a
INDUSTRY
Responsible Party
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Locations
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AZ Jan Palfijn Gent
Ghent, , Belgium
Nemocnica Bory - Penta Hospital
Bratislava, , Slovakia
Countries
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Central Contacts
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Facility Contacts
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Libor Necas
Role: primary
Role: backup
Other Identifiers
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K-23
Identifier Type: -
Identifier Source: org_study_id
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