Status:
COMPLETED
Persona TKA With iASSIST Knee System and iASSIST Knee System
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Cont...
Detailed Description
Objective： To compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using t...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, a patient must meet all of the following 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
- Absolute contraindications include:
- 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.
Key Trial Info
Start Date :
August 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2019
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT03227692
Start Date
August 18 2017
End Date
December 2 2019
Last Update
July 2 2020
Active Locations (3)
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1
Sumitomo Hopital
Osaka, Osaka, Japan, 530-0005
2
Japanese Red Cross Medical Center
Shibuya City, Tokyo, Japan, 150-8935
3
Yamaguchi Prefectural Grand Medical Center
Hōfu, Yamaguchi, Japan, 747-8511