Prospective Multi-Center Study on Vanguard With E1 Bearing

Osteoarthritis, Knee Clinical Trial

— VGRDE1  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02088372
• Other study ID #: INT.CR.GK4
• Status: Terminated
• Start date: November 2012
• Est. completion date: February 2021

Study information

• Verified date: October 2022
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: February 2021
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Osteoarthritis, Knee
• Posttraumatic Deformity
• Unspecified Disorder of Knee Joint
• Valgus Deformity
• Varus Deformity

Intervention

Device:
• Vanguard with E1 PS Bearing
Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	KOOS	Knee injuries & Osteoarthritis Outcome Score	6 Months
Secondary	KOOS	Knee injuries & Osteoarthritis Outcome Score	1 Year
Secondary	KOOS	Knee injuries & Osteoarthritis Outcome Score	3 Years
Secondary	KOOS	Knee injuries & Osteoarthritis Outcome Score	5 Years
Secondary	EQ5D	standardised instrument for use as a measure of health outcome.	6 Months
Secondary	EQ5D	standardised instrument for use as a measure of health outcome.	1 Year
Secondary	EQ5D	standardised instrument for use as a measure of health outcome.	3 Years
Secondary	EQ5D	standardised instrument for use as a measure of health outcome.	5 Years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Radiographic Assessment	Radiographic Evaluation	Immediate Post-op(2 - 4 Weeks)
Secondary	Radiographic Assessment	Radiographic Evaluation	6 Months
Secondary	Radiographic Assessment	Radiographic Evaluation	1 Year
Secondary	Radiographic Assessment	Radiographic Evaluation	3 Years
Secondary	Radiographic Assessment	Radiographic Evaluation	5 Years