Back to resultsPersona TKA With iASSIST Knee System and iASSIST Knee System
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Persona Knee System
Total Knee Arthroplasty
iAssist Knee
Sponsored by
About this trial
This is an interventional supportive care trial for Osteoarthritis, Knee
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.
Sites / Locations
- Sumitomo Hopital
- Japanese Red Cross Medical Center
- Yamaguchi Prefectural Grand Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Persona with iASSIST Knee
Persona without iASSIST Knee
Arm Description
Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.
Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Surgery Time
Surgery time from skin incision to closure
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03227692
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 18, 2017 (Actual)
Primary Completion Date
November 14, 2019 (Actual)
Study Completion Date
December 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
At surgery, intervention group using iASSIST Knee system. At surgery, conventional group not using iASSIST Knee system.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Persona TKA with iASSIST Knee system (Investigational group) or Persona TKA with conventional instrumentation (Control group). The randomization scheme is based on equal numbers per group. The randomization will occur via a random number generator (computer) using blocked randomization procedure. The PI or his/her team does not have influence on the randomization scheme. Sealed opaque envelopes, which will be prepared based on predetermined randomization assignment, will be provided to each study site before study initiation.
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Persona with iASSIST Knee
Arm Type
Experimental
Arm Description
Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.
Arm Title
Persona without iASSIST Knee
Arm Type
Active Comparator
Arm Description
Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.
Intervention Type
Device
Intervention Name(s)
Persona Knee System
Other Intervention Name(s)
Persona Knee
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Total Knee Arthroplasty
Other Intervention Name(s)
TKA
Intervention Description
Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.
Intervention Type
Device
Intervention Name(s)
iAssist Knee
Intervention Description
Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.
Primary Outcome Measure Information:
Title
Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain
Description
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.
Time Frame
Postoperative 6 months
Title
Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain
Description
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.
Time Frame
Postoperative 6 months
Title
Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain
Description
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.
Time Frame
Postoperative 6 months
Title
Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain
Description
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.
Time Frame
Postoperative 6 months
Secondary Outcome Measure Information:
Title
Surgery Time
Description
Surgery time from skin incision to closure
Time Frame
Intraoperative, an average of 2 hours
Title
Number of Instrument Trays Used
Description
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.
Time Frame
Intraoperative
Title
KSS - Objective Score at 6 Month Postoperatively
Description
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.
Time Frame
6 month postoperative
Title
KSS-Patient Satisfaction at 6 Month Postoperatively
Description
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.
Time Frame
6 month postoperative
Title
KSS-function Score at 6 Month Postoperatively
Description
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.
Time Frame
6 month postoperative
Title
KSS-Patient Expectations at 6 Month Postoperatively
Description
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.
Time Frame
6 month postoperative
Title
Oxford Knee Score at 6 Month Postoperatively
Description
Patient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome.
Time Frame
6 month postoperative
Title
EQ-5D-3L at 6 Month Postoperatively
Description
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.
Time Frame
6 month postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshihiro Ohdera, M.D.
Organizational Affiliation
Fukuoka Orthopaedic Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sumitomo Hopital
City
Ōsaka
State/Province
Osaka
ZIP/Postal Code
530-0005
Country
Japan
Facility Name
Japanese Red Cross Medical Center
City
Shibuya
State/Province
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
Yamaguchi Prefectural Grand Medical Center
City
Hōfu
State/Province
Yamaguchi
ZIP/Postal Code
747-8511
Country
Japan
12. IPD Sharing Statement
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Persona TKA With iASSIST Knee System and iASSIST Knee System
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