Persona TKA With iASSIST Knee System and iASSIST Knee System

Randomized Controlled Study Comparing iASSIST Knee System Versus Conventional Instrumentation

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Persona Knee System; Procedure: Total Knee Arthroplasty; Device: iAssist Knee

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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Osaka
    • Ōsaka, Osaka, Japan, 530-0005
      • Sumitomo Hopital
  • Tokyo
    • Shibuya, Tokyo, Japan, 150-8935
      • Japanese Red Cross Medical Center
  • Yamaguchi
    • Hōfu, Yamaguchi, Japan, 747-8511
      • Yamaguchi Prefectural Grand Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Persona with iASSIST Knee; Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.	Device: 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.; Other Names: Persona Knee; Procedure: Total Knee Arthroplasty; Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.; Other Names: TKA; Device: iAssist Knee; Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.
ACTIVE_COMPARATOR: 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.	Device: 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.; Other Names: Persona Knee; Procedure: Total Knee Arthroplasty; Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.; Other Names: TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain	Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.	Postoperative 6 months
Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain	Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.	Postoperative 6 months
Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain	Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.	Postoperative 6 months
Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain	Ratio of subject, whose knee implant is positioned within 3 degrees from preoperatively determined target angle, is compared between groups by CT data taken at 6 month after surgery.	Postoperative 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery Time	Surgery time from skin incision to closure	Intraoperative, an average of 2 hours
Number of Instrument Trays Used	Number of instrument trays used instraoperatively. This number includes number of Total Knee Arthroplasty specific instrument tray, does not include other general surgical instruments/kits.	Intraoperative
KSS - Objective Score at 6 Month Postoperatively	KSS-Objective score is physician-derived component and allows for more than 100 points in patients with greater than 125° of flexion and a stable painless knee as outlined below. Lowest possible score is 0. Higher score means better outcomes.	6 month postoperative
KSS-Patient Satisfaction at 6 Month Postoperatively	KSS-Patient Satisfaction is patient-derived score and is a five-question 40-point scale that is collected preoperatively and at each follow-up visit. Lowest possible score is 0.	6 month postoperative
KSS-function Score at 6 Month Postoperatively	KSS-function score is patient-derived score and composed of four subgroups and has a maximum score of 100. "Walking and Standing" has a maximum value of 30 points, "Standard Activities" has a maximum of 30 points, "Advanced Activities" has a maximum of 25 points and "Discretionary Activities" has a maximum of 15 points. Lowest possible score is 0. Higher score means better outcomes.	6 month postoperative
KSS-Patient Expectations at 6 Month Postoperatively	KSS-Patient Expectations is patient-derived score and is a three-question fifteen-point scale that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that operation will improve knee pain, and ability to perform activities of daily living and recreational activities. The post-operative questions reflect the extent to which postoperative outcome has met the patient's pre-operative expectations with respect to pain and function. The score ranges from 3 to 15. Higher score means better outcomes.	6 month postoperative
Oxford Knee Score at 6 Month Postoperatively	Patient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome.	6 month postoperative
EQ-5D-3L at 6 Month Postoperatively	EQ-5D is patient reported outcome measure to score patient's health related quality of life with minimum score of -0.111 and maximum score of 1.000. Higher score means better outcomes.	6 month postoperative

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Toshihiro Ohdera, M.D., Fukuoka Orthopaedic Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 18, 2017
• Primary Completion (ACTUAL): November 14, 2019
• Study Completion (ACTUAL): December 2, 2019

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (ACTUAL): July 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: K.CR.I.AP.16.39

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes