NCT02695329

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

May 24, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2018

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 3, 2019

Completed
Last Updated

February 12, 2020

Status Verified

January 1, 2020

Enrollment Period

2.4 years

First QC Date

February 19, 2016

Results QC Date

June 25, 2019

Last Update Submit

January 31, 2020

Conditions

Osteoarthritis, Knee

Keywords

navigation systempalm-sizedtotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • 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.

    Postoperative 6 months

Secondary Outcomes (3)

  • Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold

    Postoperative 6 months

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

    Postoperative 6 months

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

    Intra-operative and Post-operative 6 months

Study Arms (2)

Vanguard with KneeAlign 2

ACTIVE COMPARATOR

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

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.

Interventions

KneeAlign 2DEVICE

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.

Also known as: KneeAlign2
Vanguard with KneeAlign 2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka City University

Osaka, 558-0022, Japan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Limitations and Caveats

Image assessment, which is primary endpoint, was done on 2D x-ray (not based on CT).

Results Point of Contact

Title
Clinical Affairs Senior Manager
Organization
Zimmer Biomet G.K.
takahito.nakai@zimmerbiomet.com
+81-6402-6777

Study Officials

  • Yukihide Minoda

    Osaka City University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2016

First Posted

March 1, 2016

Study Start

May 24, 2016

Primary Completion

October 3, 2018

Study Completion

October 26, 2018

Last Updated

February 12, 2020

Results First Posted

October 3, 2019

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)