Overview

This trial is active, not recruiting.

Conditions varus deformity, valgus deformity, posttraumatic deformity, osteoarthritis, knee, unspecified disorder of knee joint
Treatment vanguard with e1 ps bearing
Sponsor Biomet, Inc.
Start date November 2012
End date December 2014
Trial size 200 participants
Trial identifier NCT02088372, INT.CR.GK4

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
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.
vanguard with e1 ps bearing
Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population

Primary Outcomes

Measure
Knee Society Score
time frame: 1 year

Secondary Outcomes

Measure
Knee Sociey Score
time frame: 6 Months
Knee Society Score
time frame: 3 Years
Knee Society Score
time frame: 5 Years
KOOS
time frame: 6 Months
KOOS
time frame: 1 Year
KOOS
time frame: 3 Years
KOOS
time frame: 5 Years
EQ5D
time frame: 6 Months
EQ5D
time frame: 1 Year
EQ5D
time frame: 3 Years
EQ5D
time frame: 5 Years
Modified University of California Los Angeles (UCLA) Activity Score
time frame: 6 Months
Modified University of California Los Angeles (UCLA) Activity Score
time frame: 1 Year
Modified University of California Los Angeles (UCLA) Activity Score
time frame: 3 Years
Modified University of California Los Angeles (UCLA) Activity Score
time frame: 5 Years
Radiographic Assessment
time frame: Immediate Post-op(2 - 4 Weeks)
Radiographic Assessment
time frame: 6 Months
Radiographic Assessment
time frame: 1 Year
Radiographic Assessment
time frame: 3 Years
Radiographic Assessment
time frame: 5 Years

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

Official title Evaluate Clinical Performance of Vanguard Knee With E1 Bearing in Korean Patient Population
Principal investigator Young Mo Kim, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..