NCT01010269

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2009

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

3 years

First QC Date

October 26, 2009

Last Update Submit

June 21, 2018

Conditions

OsteoarthritisRheumatoid ArthritisTraumatic Arthritis

Outcome Measures

Primary Outcomes (1)

  • American Knee Society Knee Score

    Including ROM

    1 Year postop

Secondary Outcomes (4)

  • Kinematic Fluoroscopic Analysis

    3 yr

  • Gait Lab Analysis

    3 yr

  • EQ5D

    3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr

  • Radiographic Assessment

    immediate postop, 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr

Study Arms (2)

Vanguard Complete Knee

ACTIVE COMPARATOR

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 High Flex RP

ACTIVE COMPARATOR

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

Interventions

Vanguard Complete KneeDEVICE

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

Vanguard Complete Knee
Vanguard High Flex RPDEVICE

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.

Vanguard High Flex RP

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul Nat'l Uni. Hospital

Seoul, South Korea

Location

The Catholic Uni. of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

OsteoarthritisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2009

First Posted

November 10, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2017

Last Updated

June 26, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(4)