Kinematic- Versus Ligament-balanced Mechanical Alignment in TKA
NCT ID: NCT04436211
Last Updated: 2020-06-17
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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UNKNOWN
100 participants
OBSERVATIONAL
2020-02-15
2022-03-30
Brief Summary
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Although first series have shown satisfying results, further verification by prospective studies and final meta-analyses will be required.
Thus, the kinematic alignment represents one of the few new developments in TKA.
Provided that patients are willing to participate in the study, patients data are collected preoperatively and during routine follow-up examinations and evaluated prospectively. Patients will receive either a conventionally mechanical aligned arthroplasty or a kinematical aligned TKA, according to a randomized procedure.
The kinematic alignment will be achieved by the use of custom-made cutting-blocks. Therefore, the patients will undergo a computed tomography of the whole leg on the affected side. This is mandatory in order to provide the individually produced cutting blocks.
In order to ensure comparability, patients are stratified regarding their age and gender before inclusion.
Outcome will be measured by the use of standard scoring systems regarding function, pain and ROM (range of motion) three, six and 12 months after surgery.
This study is a monocentric, prospective, randomized and controlled open study.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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TKA (mechanical alignment)
Total Knee Arthroplasty
The common procedure of Total Knee Arthroplasty is investigated in order to compare the techniques of implantation (kinematic vs mechanical alignment)
TKA (kinematic alignment)
Total Knee Arthroplasty
The common procedure of Total Knee Arthroplasty is investigated in order to compare the techniques of implantation (kinematic vs mechanical alignment)
Interventions
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Total Knee Arthroplasty
The common procedure of Total Knee Arthroplasty is investigated in order to compare the techniques of implantation (kinematic vs mechanical alignment)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
50 Years
ALL
Yes
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Locations
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Medical University of Graz
Graz, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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032020
Identifier Type: -
Identifier Source: org_study_id
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