Vanguard TKA With KneeAlign 2 and Without KneeAlign 2

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695329
• Other study ID #: ORTHO.CR.GK53
• Status: Completed
• Phase: N/A
• Start date: May 24, 2016
• Est. completion date: October 26, 2018

Study information

• Verified date: January 2020
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 26, 2018
• Est. primary completion date: October 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Device:
• KneeAlign 2
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.

Locations

Country	Name	City	State
Japan	Osaka City University	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Japan, 

Outcome

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