Clinical trial NCT02088372: Prospective Multi-Center Study on Vanguard With E1 Bearing
Official title: Evaluate Clinical Performance of Vanguard Knee With E1 Bearing in Korean Patient Population
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Varus Deformity
Valgus Deformity
Posttraumatic Deformity
Osteoarthritis, Knee
Unspecified Disorder of Knee Joint
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2014-03-14
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Society Score
timeFrame: 1 year
Secondary outcomes:
measure: Knee Sociey Score
timeFrame: 6 Months
measure: Knee Society Score
timeFrame: 3 Years
measure: Knee Society Score
timeFrame: 5 Years
measure: KOOS
timeFrame: 6 Months
measure: KOOS
timeFrame: 1 Year
measure: KOOS
timeFrame: 3 Years
measure: KOOS
timeFrame: 5 Years
measure: EQ5D
timeFrame: 6 Months
measure: EQ5D
timeFrame: 1 Year
measure: EQ5D
timeFrame: 3 Years
measure: EQ5D
timeFrame: 5 Years
measure: Modified University of California Los Angeles (UCLA) Activity Score
timeFrame: 6 Months
measure: Modified University of California Los Angeles (UCLA) Activity Score
timeFrame: 1 Year
measure: Modified University of California Los Angeles (UCLA) Activity Score
timeFrame: 3 Years
measure: Modified University of California Los Angeles (UCLA) Activity Score
timeFrame: 5 Years
measure: Radiographic Assessment
timeFrame: Immediate Post-op(2 - 4 Weeks)
measure: Radiographic Assessment
timeFrame: 6 Months
measure: Radiographic Assessment
timeFrame: 1 Year
measure: Radiographic Assessment
timeFrame: 3 Years
measure: Radiographic Assessment
timeFrame: 5 Years
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Kangwon Nat'l Univ. Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam Nat'l Univ. Hospital
city: Incheon
country: Korea, Republic of
facility: Gacheon Gil Univ. Gil Medical Center
city: Jeonju
country: Korea, Republic of
facility: Chonbuk Nat'l Univ. Hospital
Study officials:
affiliation: Chungnam Nat'l Univ. Hospital
name: Young Mo Kim, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Kangwon Nat'l Univ. Hospital
name: Kye Young Han, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Gacheon Uni. Gil Medical Center
name: Jae Ang Shim, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk Nat'l Univ. Hospital
name: Joo Hong Lee, Ph. D
role: PRINCIPAL_INVESTIGATOR
References: