Study Results
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View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2016-05-24
2018-10-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Vanguard with KneeAlign 2
Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2.
KneeAlign 2
Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.
Vanguard without KneeAlign 2
Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.
No interventions assigned to this group
Interventions
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KneeAlign 2
Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects willing to return for follow-up evaluations
Exclusion Criteria
* Severe OA deformation (FTA: \>185 degrees or \<175 degrees)
* Active Infection (or within 6 weeks after infection)
* Sepsis
* Osteomyelitis
* Any type of implant is inserted in the affected side of lower extremity
* Hip disease on the affected side
* Uncooperative patient or patient with neurologic disorders who are incapable of following directions
* diagnosed Osteoporosis or Osteomalacia
* Metabolic disorders which may impair bone formation
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy or neuromuscular disease.
20 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Yukihide Minoda
Role: PRINCIPAL_INVESTIGATOR
Osaka City University
Locations
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Osaka City University
Osaka, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ORTHO.CR.GK53
Identifier Type: -
Identifier Source: org_study_id
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