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Completed

NCT Number: NCT02695329

Vanguard TKA With KneeAlign 2 and Without KneeAlign 2

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

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Osaka City University

Osaka, 558-0022, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KneeAlign 2

Device

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.

Other names: KneeAlign2

Primary outcomes

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

    Time frame: 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 outcomes

  1. Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold

    Time frame: Postoperative 6 months

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

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

    Time frame: Postoperative 6 months

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

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

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

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

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 1, 2016
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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