Persona TKA With iASSIST Knee System and iASSIST Knee System

Osteoarthritis, Knee Clinical Trial

Official title:

Randomized Controlled Study Comparing iASSIST Knee System Versus Conventional Instrumentation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03227692
• Other study ID #: K.CR.I.AP.16.39
• Status: Completed
• Phase: N/A
• Start date: August 18, 2017
• Est. completion date: December 2, 2019

Study information

• Verified date: January 2020
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 2, 2019
• Est. primary completion date: November 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

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.

Procedure:
• Total Knee Arthroplasty
Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.

Device:
• iAssist Knee
Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.

Locations

Country	Name	City	State
Japan	Yamaguchi Prefectural Grand Medical Center	Hofu	Yamaguchi
Japan	Sumitomo Hopital	Osaka	Osaka
Japan	Japanese Red Cross Medical Center	Shibuya	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Surgery Time	Surgery time from skin incision to closure	Intraoperative, an average of 2 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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