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Completed

NCT Number: NCT01010269

Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study

The purpose of this study is to compare Vanguard High Flex Rotating Platform to Vanguard Complete Knee System in Asian population in terms of early range of motion (ROM), clinical outcomes, and kinetic and kinematic characteristics in relation to healthy knees.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center, Seoul, South Korea

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About this study

The primary objectives of this clinical study include:

  • Evaluate size fit and long term performance of Vanguard Complete Knee ("Fixed") System in Asian and Latino population in comparison to competitor's similar product.
  • Evaluate efficacy of Vanguard Complete Knee with Microplasty Tibial Tray.
  • Compare Vanguard High Flex Rotating Platform ("High Flex") Knee System to Vanguard Complete Knee System in Asian population in terms of:
  • Early ROM
  • Clinical outcomes
  • Kinetic and Kinematic characteristics in relation to Healthy Knees. o
  • Compare current design to new design of Vanguard High Flex Rotating Platform Knee System in terms of :
  • Early ROM
  • Clinical outcomes
  • Kinetic and Kinematic characteristics

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Painful and disabled knee joint resulting form osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
  • Correction of varus, valgus, or posttraumatic deformity.
  • Correction or revision of unsuccessful osteotomy, or arthrodesis.
  • Need to obtain pain relief and improve function.
  • Ability and willingness of the patient to follow instructions, including control of weight and activity level.
  • Good nutritional state of the patient.
  • Patient must have reached full skeletal maturity.

Exclusion criteria

  • Infection, sepsis, osteomyelitis, and failure of previous joint replacement.
  • Uncooperative patient or patients with neurologic disorders who are incapable of following directions.
  • Osteoporosis
  • Metabolic disorders which may impair bone formation
  • Osteomalacia
  • 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, neuromuscular disease
  • Incomplete or deficient soft tissue surrounding the knee

Treatment and study plan

Vanguard Complete Knee

Device

Vanguard Knee is a metal and polyethylene system indicated for cemented tibial and femoral use.

Vanguard High Flex RP

Device

Vanguard High Flex RP is an extension to the existing Vanguard Knee and has been specifically designed to facilitate greater than 135 degrees of knee flexion.

Primary outcomes

  1. American Knee Society Knee Score

    Time frame: 1 Year postop

    Including ROM

Secondary outcomes

  1. Kinematic Fluoroscopic Analysis

    Time frame: 3 yr

    Kinematic Fluoroscopic Analysis

  2. Gait Lab Analysis

    Time frame: 3 yr

    Gait Lab Analysis

  3. EQ5D

    Time frame: 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr

    Quality of Life

  4. Radiographic Assessment

    Time frame: immediate postop, 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr

    Radiographic Assessment

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

A Prospective Controlled Multi-center Study on Vanguard Complete Knee and Vanguard High Flex RP Knee

Important dates

Study start
2009
Primary completion
2012
Study completion
2017
First posted
Nov 10, 2009
Registry last updated
Jun 26, 2018

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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