Vanguard TKA With KneeAlign 2 and Without KneeAlign 2

Zimmer Biomet100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

100

Conditions

Osteoarthritis, Knee

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

Osaka City University

Osaka, Japan

Outcomes

Primary Outcomes

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.

Time frame: Postoperative 6 months

Secondary Outcomes

Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold

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

Time frame: 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)

Time frame: 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

Time frame: Intra-operative and Post-operative 6 months

Data from ClinicalTrials.gov

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