Vanguard TKA With KneeAlign 2 and Without KneeAlign 2

A study testing KneeAlign 2 in people with Osteoarthritis, Knee, run by Zimmer Biomet at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments 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?: KneeAlign 2
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteJapan
Study dates: 24 May 2016to 26 Oct 2018
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

Knee (either unilateral or bilateral) Osteoarthritis (varus deformity only)
Subjects willing to return for follow-up evaluations

Who cannot join

Knee degenerative diseases other than Knee Osteoarthritis (such as necrosis / Rheumatoid Arthritis)
Severe OA deformation (FTA: >185 degrees or <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

Show all 13Show fewer

Hip disease on the affected side
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

1 site in 1 country.

Japan1 site

Osaka City University
Osaka, 558-0022

Other trials in Japan

About this study

Official title: Randomized Controlled Study Comparing Vanguard With KneeAlign2 Navigational System Versus Vanguard Conventional

Read the detailed description

Conditions: Osteoarthritis, Knee
Being tested: KneeAlign 2
Keywords: navigation system, palm-sized, total knee arthroplasty
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KneeAlign 2Device
Also called KneeAlign2
Patients suffering non-severe varus deformity 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.

Study groups in NCT02695329
Study group	Role	What they receive
Vanguard with KneeAlign 2	Active comparator	Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2. Receives: Device: KneeAlign 2
Vanguard without KneeAlign 2	No intervention	Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia
Proportion of subjects that have tibial alignment within 2 degrees from neutral and compare the accuracy of tibial component alignment between two groups.
Measured: Postoperative 6 months

Secondary outcomes (3)

Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold
Deviation of tibial posterior slope angle from preoperative planned angle (within 2 degrees)
Measured: Postoperative 6 months
Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold
Deviation of femoral valus/valgus angle from preoperative planned angle (within 2 degrees)
Measured: Postoperative 6 months
Number of Participants With Adverse Events and/or Adverse Device Effects
Number of participants, who experience adverse events and/or adverse device effects
Measured: Intra-operative and Post-operative 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 201626 Oct 2018

First posted1 Mar 2016 (estimated)
Study start24 May 2016
Primary completion3 Oct 2018
Study completion26 Oct 2018

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
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02695329
Sponsor's protocol ID: ORTHO.CR.GK53
Status last verified: Jan 2020
First submitted: 19 Feb 2016
Last updated: 12 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Study Comparing Vanguard With KneeAlign2 Navigational System Versus Vanguard Conventional
ClinicalTrials.gov ID: NCT02695329
Acronym / sponsor ID: ORTHO.CR.GK53
Conditions: Osteoarthritis, Knee
Keywords: navigation system, palm-sized, total knee arthroplasty
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: 24 May 2016 (actual)
Primary completion: 3 Oct 2018 (actual)
Study completion: 26 Oct 2018 (actual)
First posted: 1 Mar 2016 (estimated)
Results: Posted 3 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Vanguard with KneeAlign 2	Active comparator	Device: KneeAlign 2Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2.
Vanguard without KneeAlign 2	No intervention	–Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Knee (either unilateral or bilateral) Osteoarthritis (varus deformity only)
Subjects willing to return for follow-up evaluations

Key exclusion criteria (13 listed)

Knee degenerative diseases other than Knee Osteoarthritis (such as necrosis / Rheumatoid Arthritis)
Severe OA deformation (FTA: >185 degrees or <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
KneeAlign 2Also: KneeAlign2Patients suffering non-severe varus deformity 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.	Device	Vanguard with KneeAlign 2

Primary outcome

Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia
Time frame: Postoperative 6 months
Proportion of subjects that have tibial alignment within 2 degrees from neutral and compare the accuracy of tibial component alignment between two groups.

3 secondary outcomes

Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold
Time frame: Postoperative 6 months
Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold
Time frame: Postoperative 6 months
Number of Participants With Adverse Events and/or Adverse Device Effects
Time frame: Intra-operative and Post-operative 6 months

Results and safety

Results posted to the registry on 3 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vanguard With KneeAlign 2	50	45
Vanguard Without KneeAlign 2	50	45

Primary outcome: Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia

Time frame: Postoperative 6 months. Count of participants. Unit: Participants

Measure	Vanguard With KneeAlign 2 n = 45	Vanguard Without KneeAlign 2 n = 45
within 2 degrees (success)	41	31
outlier (failure)	4	14

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From surgery to 6 month visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vanguard With KneeAlign 2	0 of 50 (0%)	1 of 50 (2%)	0 of 50
Vanguard Without KneeAlign 2	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Limitations and caveats (from the sponsor): Image assessment, which is primary endpoint, was done on 2D x-ray (not based on CT).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis, Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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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.

Yukihide Minoda principal investigator

Osaka City University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing KneeAlign 2 in people with Osteoarthritis, Knee, run by Zimmer Biomet at 1 site 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 2 inclusion and 13 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 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 Oct 2019). 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?

Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia (time frame: Postoperative 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02695329.

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 12 Feb 2020.