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 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Device: Vanguard Complete Knee System w/ std tray
Device: Vanguard High Flex RP

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Controlled Multi-center Study on Vanguard Complete Knee and Vanguard High Flex RP Knee

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • American Knee Society Knee Score, including ROM [ Time Frame: 1 Year postop ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: October 2009
Estimated Study Completion Date: October 2021
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vanguard Complete Knee System w/ std tray Device: Vanguard Complete Knee System w/ std tray
Vanguard Knee is a metal and polyethylene system indicated for cemented tibial and femoral use.
Active Comparator: Vanguard High Flex RP 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.

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010269

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Biomet, Inc.
Investigators
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
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01010269     History of Changes
Other Study ID Numbers: ROW1
Study First Received: October 26, 2009
Last Updated: September 30, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014