NCT02088372

Brief Summary

Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
terminated

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

November 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

October 21, 2022

Status Verified

October 1, 2022

Enrollment Period

2.1 years

First QC Date

March 13, 2014

Last Update Submit

October 18, 2022

Conditions

Varus DeformityValgus DeformityPosttraumatic DeformityOsteoarthritis, KneeUnspecified Disorder of Knee Joint

Outcome Measures

Primary Outcomes (1)

  • Knee Society Score

    scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA

    1 year

Secondary Outcomes (20)

  • Knee Sociey Score

    6 Months

  • Knee Society Score

    3 Years

  • Knee Society Score

    5 Years

  • KOOS

    6 Months

  • KOOS

    1 Year

  • +15 more secondary outcomes

Study Arms (1)

Vanguard with E1 PS Bearing

E1™ Vitamin E doping of highly cross-linked polyethylene is a proposed method for insuring long-term oxidative stability of highly cross-linked ultra-high molecular weight polyethylene for use in total joint arthroplasty. Vanguard Total Knee System™ The Vanguard™ Knee System was designed to incorporate features from prior designs, including: ACG, Maxim, \& Ascent.

Device: Vanguard with E1 PS Bearing

Interventions

Vanguard with E1 PS BearingDEVICE

Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population

Vanguard with E1 PS Bearing

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Painful and disabled knee joint resulting from osteoarthritis or traumatic arthritis where one or more compartments are involved, varus, valgus, or posttraumatic deformity, and revision of unsuccessful osteotomy at Chungnam Nat'l Univ. Hospital, Kangwon Nat'l Univ. Hospital, Gacheon Uni. Gil Medical Center, and Chonbuk Nat'l Univ. Hospital.

You may qualify if:

  • Patients will be included in this study if they received Vanguard knee with E1 Bearing per the approved indications for use for Vanguard Knee. Specifically
  • Painful and disabled knee joint resulting from osteoarthritis or traumatic arthritis where one or more compartments are involved
  • Correction of varus, valgus, or posttraumatic deformity
  • Correction or revision of unsuccessful osteotomy

You may not qualify if:

  • Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement
  • Relative contraindications include:
  • Uncooperative patient or patient 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)

Kangwon Nat'l Univ. Hospital

Chuncheon, South Korea

Location

Chungnam Nat'l Univ. Hospital

Daejeon, South Korea

Location

Gacheon Gil Univ. Gil Medical Center

Incheon, South Korea

Location

Chonbuk Nat'l Univ. Hospital

Jeonju, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Young Mo Kim, Ph.D

    Chungnam Nat'l Univ. Hospital

    PRINCIPAL INVESTIGATOR

  • Kye Young Han, Ph.D

    Kangwon Nat'l Univ. Hospital

    PRINCIPAL INVESTIGATOR

  • Jae Ang Shim, Ph.D

    Gacheon Uni. Gil Medical Center

    PRINCIPAL INVESTIGATOR

  • Joo Hong Lee, Ph. D

    Chonbuk Nat'l Univ. Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 14, 2014

Study Start

November 1, 2012

Primary Completion

December 1, 2014

Study Completion

February 1, 2021

Last Updated

October 21, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(4)