Persona TKA With iASSIST Knee System and iASSIST Knee System
NCT ID: NCT03227692
Last Updated: 2020-07-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
93 participants
INTERVENTIONAL
2017-08-18
2019-12-02
Brief Summary
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Detailed Description
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Endpoint： Primary： The alignment accuracy of the knee femoral and tibial components at 6 months for the investigational group compared to the control group.
Secondary：Health Status after TKA, Operating Room efficiency and Complication rate after TKA for the investigational group compared to the control group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Persona with iASSIST Knee
Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.
Persona Knee System
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.
Total Knee Arthroplasty
Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.
iAssist Knee
Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.
Persona without iASSIST Knee
Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.
Persona Knee System
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.
Total Knee Arthroplasty
Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.
Interventions
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Persona Knee System
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.
Total Knee Arthroplasty
Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.
iAssist Knee
Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Knee (either unilateral or bilateral) osteoarthritis (varus deformity only)
* Male or female
* At least 20 years of age
* Patients willing to return for follow-up evaluations.
Study Specific Requirements for Principal Investigator/Site
* Principal Investigator (PI) must have experience of at least 5 TKAs of iASSIST Knee with Persona and Persona conventional instrument system before any study specific activities.
* Site has sufficient resources to take limb CT scanning at 6 months follow-up visit.
Exclusion Criteria
* Knee degenerative diseases other than knee osteoarthritis (such as necrosis/rheumatoid arthritis)
* Too severe OA deformation (FTA: \> 190 degrees/\< 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 and/or foot disease on the affected side
Additional contraindications include:
* 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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Toshihiro Ohdera, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fukuoka Orthopaedic Hospital
Locations
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Sumitomo Hopital
Osaka, Osaka, Japan
Japanese Red Cross Medical Center
Shibuya City, Tokyo, Japan
Yamaguchi Prefectural Grand Medical Center
Hōfu, Yamaguchi, 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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K.CR.I.AP.16.39
Identifier Type: -
Identifier Source: org_study_id
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