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Vanguard TKA With KneeAlign 2 and Without KneeAlign 2

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

KneeAlign 2

About this trial

This is an interventional supportive care trial for Osteoarthritis, Knee focused on measuring navigation system, palm-sized, total knee arthroplasty

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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.

Sites / Locations

Osaka City University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Vanguard with KneeAlign 2

Vanguard without KneeAlign 2

Arm Description

Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2.

Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold

Deviation of tibial posterior slope angle from preoperative planned angle (within 2 degrees)

Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold

Deviation of femoral valus/valgus angle from preoperative planned angle (within 2 degrees)

Number of Participants With Adverse Events and/or Adverse Device Effects

Number of participants, who experience adverse events and/or adverse device effects

Full Information

NCT ID

NCT02695329

First Posted

February 19, 2016

Last Updated

January 31, 2020

Sponsor

Zimmer Biomet

1. Study Identification

Unique Protocol Identification Number

NCT02695329

Brief Title

Vanguard TKA With KneeAlign 2 and Without KneeAlign 2

Official Title

Randomized Controlled Study Comparing Vanguard With KneeAlign2 Navigational System Versus Vanguard Conventional

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

May 24, 2016 (Actual)

Primary Completion Date

October 3, 2018 (Actual)

Study Completion Date

October 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zimmer Biomet

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

Detailed Description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

navigation system, palm-sized, total knee arthroplasty

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vanguard with KneeAlign 2

Arm Type

Active Comparator

Arm Description

Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2.

Arm Title

Vanguard without KneeAlign 2

Arm Type

No Intervention

Arm Description

Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.

Intervention Type

Device

Intervention Name(s)

KneeAlign 2

Other Intervention Name(s)

KneeAlign2

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Proportion of subjects that have tibial alignment within 2 degrees from neutral and compare the accuracy of tibial component alignment between two groups.

Time Frame

Postoperative 6 months

Secondary Outcome Measure Information:

Title

Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold

Description

Deviation of tibial posterior slope angle from preoperative planned angle (within 2 degrees)

Time Frame

Postoperative 6 months

Title

Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold

Description

Deviation of femoral valus/valgus angle from preoperative planned angle (within 2 degrees)

Time Frame

Postoperative 6 months

Title

Number of Participants With Adverse Events and/or Adverse Device Effects

Description

Number of participants, who experience adverse events and/or adverse device effects

Time Frame

Intra-operative and Post-operative 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yukihide Minoda

Organizational Affiliation

Osaka City University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Osaka City University

City

Osaka

ZIP/Postal Code

558-0022

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Vanguard TKA With KneeAlign 2 and Without KneeAlign 2

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