Osteoarthritis, KneeNCT03227692
Persona TKA With iASSIST Knee System and iASSIST Knee System
A study testing Persona Knee System, Total Knee Arthroplasty and iAssist Knee in people with Osteoarthritis, Knee, run by Zimmer Biomet at 3 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Persona Knee System, Total Knee Arthroplasty and iAssist Knee
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 3 sitesJapan
- Study dates
- 18 Aug 2017to 2 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
3 sites in 1 country.
Japan3 sites
Yamaguchi Prefectural Grand Medical Center
Hōfu, Yamaguchi, 747-8511
Sumitomo Hopital
Osaka, Osaka, 530-0005
Japanese Red Cross Medical Center
Shibuya City, Tokyo, 150-8935
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Persona Knee System, Total Knee Arthroplasty, iAssist Knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persona Knee SystemDevice
Also called Persona Knee
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.
Total Knee ArthroplastyProcedure or surgery
Also called TKA
Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.
iAssist KneeDevice
Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.
| Study group | Role | What they receive |
|---|---|---|
| Persona with iASSIST Knee | Experimental | Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee. Receives: Device: Persona Knee System; Procedure: Total Knee Arthroplasty; Device: iAssist Knee |
| Persona without iASSIST Knee | Active comparator | Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee. Receives: Device: Persona Knee System; Procedure: Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative 6 months
Secondary outcomes (8)
Surgery Time
Surgery time from skin incision to closure
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start18 Aug 2017
- Primary completion14 Nov 2019
- Study completion2 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At surgery, intervention group using iASSIST Knee system. At surgery, conventional group not using iASSIST Knee system.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshihiro Ohdera, M.D., Principal investigator, Fukuoka Orthopaedic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227692
- Sponsor's protocol ID
- K.CR.I.AP.16.39
- Status last verified
- Jan 2020
- First submitted
- 20 Jul 2017
- Last updated
- 2 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study Comparing iASSIST Knee System Versus Conventional Instrumentation
- ClinicalTrials.gov ID
- NCT03227692
- Acronym / sponsor ID
- K.CR.I.AP.16.39
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 2 Dec 2019 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Posted 19 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- At surgery, intervention group using iASSIST Knee system. At surgery, conventional group not using iASSIST Knee system.
| Arm | Type | Receives |
|---|---|---|
| Persona with iASSIST Knee | Experimental | Device: Persona Knee System, Procedure: Total Knee Arthroplasty, Device: iAssist KneeHaving total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee. |
| Persona without iASSIST Knee | Active comparator | Device: Persona Knee System, Procedure: Total Knee ArthroplastyHaving total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Persona Knee SystemAlso: Persona KneeOsteoarthritis 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. | Device | Persona with iASSIST Knee, Persona without iASSIST Knee |
| Total Knee ArthroplastyAlso: TKADamaged cartilage due to degerative arthritis is replaced by knee joint prosthesis. | Procedure or surgery | Persona with iASSIST Knee, Persona without iASSIST Knee |
| iAssist KneeOsteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone. | Device | Persona with iASSIST Knee |
Primary outcome
Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain
Time frame: Postoperative 6 months
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
Time frame: Postoperative 6 months
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
Time frame: Postoperative 6 months
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
Time frame: Postoperative 6 months
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.
8 secondary outcomes
Surgery Time
Time frame: Intraoperative, an average of 2 hours
Number of Instrument Trays Used
Time frame: Intraoperative
KSS - Objective Score at 6 Month Postoperatively
Time frame: 6 month postoperative
KSS-Patient Satisfaction at 6 Month Postoperatively
Time frame: 6 month postoperative
KSS-function Score at 6 Month Postoperatively
Time frame: 6 month postoperative
KSS-Patient Expectations at 6 Month Postoperatively
Time frame: 6 month postoperative
Oxford Knee Score at 6 Month Postoperatively
Time frame: 6 month postoperative
EQ-5D-3L at 6 Month Postoperatively
Time frame: 6 month postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toshihiro Ohdera, M.D. principal investigator
Fukuoka Orthopaedic Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Persona Knee System, Total Knee Arthroplasty and iAssist Knee in people with Osteoarthritis, Knee, run by Zimmer Biomet at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain (time frame: Postoperative 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.