Prospective Multi-Center Study on Vanguard With E1 Bearing (VGRDE1)

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

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

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis, Knee; Posttraumatic Deformity; Varus Deformity; Valgus Deformity; Unspecified Disorder of Knee Joint
• Intervention / Treatment: Device: Vanguard with E1 PS Bearing

Detailed Description

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. In vitro research and development studies have shown that this material has improved wear performance, retention of mechanical properties, and a high resistance to oxidation due to the anti-oxidative properties of Vitamin E. Biomet Inc, has received FDA clearance to market tibial polyethylene components made of E1™ for use in the Vanguard total knee replacement system.

Vanguard Total Knee System™ The Vanguard™ Knee System was designed to incorporate features from prior designs, including: ACG, Maxim, & Ascent. The Vanguard Knee includes a streamlined design, rounded sagittal profile, and a deeper trochlear groove. The femoral component is available in Cruciate Retaining (CR), Posterior Stabilizing (PS), and Super Stabilized (SSK). Tibial Bearings are available in various levels of constraint required by the surgeon (CR, PS, AS, etc.).

For this study, ONLY Vanguard with PS Bearing will be used.

The purpose of the study is to evaluate clinical performance of Vanguard Knee with E1 Bearing in TKA in Korean patient population. The clinical performance will be evaluated based on patient outcomes, radiographic assessment and survivorship.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chuncheon, Korea, Republic of
    • Kangwon Nat'l Univ. Hospital
  • Daejeon, Korea, Republic of
    • Chungnam Nat'l Univ. Hospital
  • Incheon, Korea, Republic of
    • Gacheon Gil Univ. Gil Medical Center
  • Jeonju, Korea, Republic of
    • Chonbuk Nat'l Univ. Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Exclusion Criteria for this study should comply with the stated contraindications on package inserts of Vanguard™ Knee and the E1™ Tibial Bearing. These indications are stated below:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified University of California Los Angeles (UCLA) Activity Score	It asks patients to rate their activity level from 1 to 10, with 1 defined as "no physical activity" and 10 defined as "regular participation in impact sports". The UCLA scale has demonstrated construct validity, excellent reliability, and the best completion rates.	6 Months
Knee Sociey Score	scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA	6 Months
Knee Society Score	scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA	3 Years
Knee Society Score	scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA	5 Years
KOOS	Knee injuries & Osteoarthritis Outcome Score	6 Months
KOOS	Knee injuries & Osteoarthritis Outcome Score	1 Year
KOOS	Knee injuries & Osteoarthritis Outcome Score	3 Years
KOOS	Knee injuries & Osteoarthritis Outcome Score	5 Years
EQ5D	standardised instrument for use as a measure of health outcome.	6 Months
EQ5D	standardised instrument for use as a measure of health outcome.	1 Year
EQ5D	standardised instrument for use as a measure of health outcome.	3 Years
EQ5D	standardised instrument for use as a measure of health outcome.	5 Years
Modified University of California Los Angeles (UCLA) Activity Score	It asks patients to rate their activity level from 1 to 10, with 1 defined as "no physical activity" and 10 defined as "regular participation in impact sports". The UCLA scale has demonstrated construct validity, excellent reliability, and the best completion rates.	1 Year
Modified University of California Los Angeles (UCLA) Activity Score	It asks patients to rate their activity level from 1 to 10, with 1 defined as "no physical activity" and 10 defined as "regular participation in impact sports". The UCLA scale has demonstrated construct validity, excellent reliability, and the best completion rates.	3 Years
Modified University of California Los Angeles (UCLA) Activity Score	It asks patients to rate their activity level from 1 to 10, with 1 defined as "no physical activity" and 10 defined as "regular participation in impact sports". The UCLA scale has demonstrated construct validity, excellent reliability, and the best completion rates.	5 Years
Radiographic Assessment	Radiographic Evaluation	Immediate Post-op(2 - 4 Weeks)
Radiographic Assessment	Radiographic Evaluation	6 Months
Radiographic Assessment	Radiographic Evaluation	1 Year
Radiographic Assessment	Radiographic Evaluation	3 Years
Radiographic Assessment	Radiographic Evaluation	5 Years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: March 13, 2014
• First Submitted That Met QC Criteria: March 13, 2014
• First Posted (Estimate): March 14, 2014

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Congenital Abnormalities
• Other Study ID Numbers: INT.CR.GK4

Plan for Individual participant data (IPD)

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