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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis
• Intervention / Treatment: Device: Vanguard Complete Knee; Device: Vanguard High Flex RP

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

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Seoul Nat'l Uni. Hospital
  • Seoul, Korea, Republic of
    • The Catholic Uni. of Korea, Seoul St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vanguard Complete Knee; Vanguard Completed Knee with Microplasty Tibial Tray is designed to hold the tibial knee bearings in a microplsty knee procedure. The Co-Cro-Mo trays are designed with a shorter stem.	Device: Vanguard Complete Knee; Vanguard Knee is a metal and polyethylene system indicated for cemented tibial and femoral use.
Active Comparator: Vanguard High Flex RP; VGRD High Flex RP knee is an extension to the exsting Vanguard Knee and has been specifically desinged to facilitate greather than 135 degrees of knee flextion as required by certain patients.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Knee Society Knee Score	Including ROM	1 Year postop

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinematic Fluoroscopic Analysis	Kinematic Fluoroscopic Analysis	3 yr
Gait Lab Analysis	Gait Lab Analysis	3 yr
EQ5D	Quality of Life	3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr
Radiographic Assessment	Radiographic Assessment	immediate postop, 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• 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

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: October 26, 2009
• First Submitted That Met QC Criteria: November 6, 2009
• First Posted (Estimate): November 10, 2009

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 21, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: INT.CR.RROW1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No