Clinical trial NCT03227692: Persona TKA With iASSIST Knee System and iASSIST Knee System
Official title: Randomized Controlled Study Comparing iASSIST Knee System Versus Conventional Instrumentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-07-24
Enrollment: 93
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At surgery, intervention group using iASSIST Knee system. At surgery, conventional group not using iASSIST Knee system.
Primary purpose: SUPPORTIVE_CARE

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 (Control group) using the same implant system.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain
timeFrame: Postoperative 6 months
measure: Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain
timeFrame: Postoperative 6 months
measure: Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain
timeFrame: Postoperative 6 months
measure: Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain
timeFrame: Postoperative 6 months
Secondary outcomes:
measure: Surgery Time
timeFrame: Intraoperative, an average of 2 hours
measure: Number of Instrument Trays Used
timeFrame: Intraoperative
measure: KSS - Objective Score at 6 Month Postoperatively
timeFrame: 6 month postoperative
measure: KSS-Patient Satisfaction at 6 Month Postoperatively
timeFrame: 6 month postoperative
measure: KSS-function Score at 6 Month Postoperatively
timeFrame: 6 month postoperative
measure: KSS-Patient Expectations at 6 Month Postoperatively
timeFrame: 6 month postoperative
measure: Oxford Knee Score at 6 Month Postoperatively
timeFrame: 6 month postoperative
measure: EQ-5D-3L at 6 Month Postoperatively
timeFrame: 6 month postoperative
Other outcomes:
Locations:
city: Ōsaka
country: Japan
facility: Sumitomo Hopital
state: Osaka
city: Shibuya
country: Japan
facility: Japanese Red Cross Medical Center
state: Tokyo
city: Hōfu
country: Japan
facility: Yamaguchi Prefectural Grand Medical Center
state: Yamaguchi
Study officials:
affiliation: Fukuoka Orthopaedic Hospital
name: Toshihiro Ohdera, M.D.
role: PRINCIPAL_INVESTIGATOR
References: