Persona TKA With iASSIST Knee System and iASSIST Knee System

Zimmer Biomet

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: Persona Knee System; Device: iAssist Knee; Procedure: Total Knee Arthroplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT03227692

K.CR.I.AP.16.39

Details and patient eligibility

About

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 (Control group) using the same implant system.

Full 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 the same implant system.

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.

Enrollment: 93 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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 criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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93 participants in 2 patient groups

Persona with iASSIST Knee

Experimental group

Description:

Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.

Treatment:

Device: iAssist Knee

Procedure: Total Knee Arthroplasty

Device: Persona Knee System

Persona without iASSIST Knee

Active Comparator group

Description:

Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.

Treatment:

Procedure: Total Knee Arthroplasty

Device: Persona Knee System