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

Primary Purpose

Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vanguard Complete Knee
Vanguard High Flex RP
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vanguard Complete Knee

Vanguard High Flex RP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

American Knee Society Knee Score
Including ROM

Secondary Outcome Measures

Kinematic Fluoroscopic Analysis
Kinematic Fluoroscopic Analysis
Gait Lab Analysis
Gait Lab Analysis
EQ5D
Quality of Life
Radiographic Assessment
Radiographic Assessment

Full Information

First Posted
October 26, 2009
Last Updated
June 21, 2018
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT01010269
Brief Title
Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study
Official Title
A Prospective Controlled Multi-center Study on Vanguard Complete Knee and Vanguard High Flex RP Knee
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vanguard Complete Knee
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Vanguard High Flex RP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vanguard Complete Knee
Intervention Description
Vanguard Knee is a metal and polyethylene system indicated for cemented tibial and femoral use.
Intervention Type
Device
Intervention Name(s)
Vanguard High Flex RP
Intervention Description
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 Outcome Measure Information:
Title
American Knee Society Knee Score
Description
Including ROM
Time Frame
1 Year postop
Secondary Outcome Measure Information:
Title
Kinematic Fluoroscopic Analysis
Description
Kinematic Fluoroscopic Analysis
Time Frame
3 yr
Title
Gait Lab Analysis
Description
Gait Lab Analysis
Time Frame
3 yr
Title
EQ5D
Description
Quality of Life
Time Frame
3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr
Title
Radiographic Assessment
Description
Radiographic Assessment
Time Frame
immediate postop, 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myung-Chul Lee, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chul-Won Ha, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seong-Il Bin, M.D., Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yong In, M.D., Ph.D.
Organizational Affiliation
Catholic University Uijungbu St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Nat'l Uni. Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic Uni. of Korea, Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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