Vanguard TKA With KneeAlign 2 and Without KneeAlign 2

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Device: KneeAlign 2

• Registration Number: NCT02695329
• Lead Sponsor: Zimmer Biomet

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

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.

Study Timeline

• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-02-24
• Study First Posted: 2016-03-01
• Study Start: 2016-05-24
• Primary Completion: 2018-10-03
• Study Completion: 2018-10-26
• Results First Submitted: 2019-06-25
• Results First Submitted QC: 2019-09-08
• Results First Posted: 2019-10-03
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-31
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vanguard with KneeAlign 2	KneeAlign 2	Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2.

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Osaka City University; 🇯🇵 Osaka, Japan