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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01010269
First received: October 26, 2009
Last updated: September 14, 2012
Last verified: September 2012
History of Changes

October 26, 2009
September 14, 2012
October 2009
October 2012   (final data collection date for primary outcome measure)
American Knee Society Knee Score, including ROM [ Time Frame: 1 Year postop ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01010269 on ClinicalTrials.gov Archive Site
  • Kinematic Fluoroscopic Analysis [ Time Frame: 3 yr ] [ Designated as safety issue: No ]
  • Gait Lab Analysis [ Time Frame: 3 yr ] [ Designated as safety issue: No ]
  • EQ5D [ Time Frame: 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr ] [ Designated as safety issue: No ]
  • Radiographic Assessment [ Time Frame: immediate postop, 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study
A Prospective Controlled Multi-center Study on Vanguard Complete Knee and Vanguard High Flex RP Knee

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.

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
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Traumatic Arthritis
  • Device: Vanguard Complete Knee System w/ std tray
    Vanguard Knee is a metal and polyethylene system indicated for cemented tibial and femoral use.
  • Device: Vanguard High Flex RP
    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.
  • Experimental: Vanguard Complete Knee System w/ std tray
    Intervention: Device: Vanguard Complete Knee System w/ std tray
  • Active Comparator: Vanguard High Flex RP
    Intervention: Device: Vanguard High Flex RP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
October 2021
October 2012   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01010269
ROW1
No
Biomet, Inc.
Biomet, Inc.
Not Provided
Principal Investigator: Myung-Chul Lee, M.D., Ph.D. Seoul National University Hospital
Principal Investigator: Chul-Won Ha, M.D., Ph.D. Samsung Medical Center
Principal Investigator: Seong-Il Bin, M.D., Ph.D. Asan Medical Center
Principal Investigator: Yong In, M.D., Ph.D. Catholic University Uijungbu St. Mary's Hospital
Biomet, Inc.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP