Prospective Multi-Center Study on Vanguard With E1 Bearing

Terminated

• Conditions: Posttraumatic Deformity; Osteoarthritis, Knee; Varus Deformity; Valgus Deformity; Unspecified Disorder of Knee Joint
• Interventions: Device: Vanguard with E1 PS Bearing

• Registration Number: NCT02088372
• Lead Sponsor: Zimmer Biomet

Brief Summary

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

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 Timeline

• Study Start: 2012-11
• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-14
• Primary Completion: 2014-12
• Study Completion: 2021-02
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vanguard with E1 PS Bearing	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.

Primary Outcome Measures

Name	Time	Method
Knee Society Score	1 year	scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA

Secondary Outcome Measures

Name	Time	Method
Knee Sociey Score	6 Months	scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA
Knee Society Score	5 Years	scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA
Modified University of California Los Angeles (UCLA) Activity Score	5 Years	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.
KOOS	5 Years	Knee injuries \& Osteoarthritis Outcome Score
EQ5D	5 Years	standardised instrument for use as a measure of health outcome.
Radiographic Assessment	5 Years	Radiographic Evaluation

Trial Locations

Locations (4)

Kangwon Nat'l Univ. Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Chungnam Nat'l Univ. Hospital; 🇰🇷 Daejeon, Korea, Republic of

Gacheon Gil Univ. Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of

Chonbuk Nat'l Univ. Hospital; 🇰🇷 Jeonju, Korea, Republic of