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
217 participants
OBSERVATIONAL
2019-07-01
2022-10-29
Brief Summary
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Detailed Description
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The study design is based on a two-arms design. The patients for the both groups will be recruited consecutively, starting with group A. The study will prove the equivalence of the groups regarding the outcome of the postoperative lower limb alignment (mechanical leg axis) and any deviation \>3° from neutral alignment is defined as an outlier.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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A Standard
Computer assisted primary total knee replacement with OrthoPilot FS 101 navigation system and Software 5.1
Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1
Computer Assisted Total Knee Replacement with the OrthoPilot FS101 and the software TKA 5.1
B Elite
Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0
Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0
Computer Assisted Total Knee Replacement with the with the OrthoPilot Elite and the software TKA 6.0
Interventions
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Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1
Computer Assisted Total Knee Replacement with the OrthoPilot FS101 and the software TKA 5.1
Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0
Computer Assisted Total Knee Replacement with the with the OrthoPilot Elite and the software TKA 6.0
Eligibility Criteria
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Inclusion Criteria
* Dated and signed informed consent
Exclusion Criteria
* Patients \< 18 years
* Patients unable to participate at the follow-up examination (physically, mentally)
* Previous joint replacement at the indexed knee
18 Years
80 Years
ALL
No
Sponsors
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Aesculap AG
INDUSTRY
Responsible Party
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Locations
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Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Uniklinikum Freiburg
Freiburg im Breisgau, , Germany
Schönkliniken Klinikum Eilbek
Hamburg, , Germany
Countries
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Other Identifiers
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AAG-O-H-1708
Identifier Type: -
Identifier Source: org_study_id
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