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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088372
Recruitment Status : Active, not recruiting
First Posted : March 14, 2014
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date March 13, 2014
First Posted Date March 14, 2014
Last Update Posted Date September 30, 2020
Study Start Date November 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 13, 2014)
Knee Society Score [ Time Frame: 1 year ]
scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 13, 2014)
  • Knee Sociey Score [ Time Frame: 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 [ Time Frame: 3 Years ]
    scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA
  • Knee Society Score [ Time Frame: 5 Years ]
    scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA
  • KOOS [ Time Frame: 6 Months ]
    Knee injuries & Osteoarthritis Outcome Score
  • KOOS [ Time Frame: 1 Year ]
    Knee injuries & Osteoarthritis Outcome Score
  • KOOS [ Time Frame: 3 Years ]
    Knee injuries & Osteoarthritis Outcome Score
  • KOOS [ Time Frame: 5 Years ]
    Knee injuries & Osteoarthritis Outcome Score
  • EQ5D [ Time Frame: 6 Months ]
    standardised instrument for use as a measure of health outcome.
  • EQ5D [ Time Frame: 1 Year ]
    standardised instrument for use as a measure of health outcome.
  • EQ5D [ Time Frame: 3 Years ]
    standardised instrument for use as a measure of health outcome.
  • EQ5D [ Time Frame: 5 Years ]
    standardised instrument for use as a measure of health outcome.
  • Modified University of California Los Angeles (UCLA) Activity Score [ Time Frame: 6 Months ]
    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.
  • Modified University of California Los Angeles (UCLA) Activity Score [ Time Frame: 1 Year ]
    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.
  • Modified University of California Los Angeles (UCLA) Activity Score [ Time Frame: 3 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.
  • Modified University of California Los Angeles (UCLA) Activity Score [ Time Frame: 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.
  • Radiographic Assessment [ Time Frame: Immediate Post-op(2 - 4 Weeks) ]
    Radiographic Evaluation
  • Radiographic Assessment [ Time Frame: 6 Months ]
    Radiographic Evaluation
  • Radiographic Assessment [ Time Frame: 1 Year ]
    Radiographic Evaluation
  • Radiographic Assessment [ Time Frame: 3 Years ]
    Radiographic Evaluation
  • Radiographic Assessment [ Time Frame: 5 Years ]
    Radiographic Evaluation
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Multi-Center Study on Vanguard With E1 Bearing
Official Title Evaluate Clinical Performance of Vanguard Knee With E1 Bearing in Korean Patient Population
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Varus Deformity
  • Valgus Deformity
  • Posttraumatic Deformity
  • Osteoarthritis, Knee
  • Unspecified Disorder of Knee Joint
Intervention Device: Vanguard with E1 PS Bearing
Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population
Study Groups/Cohorts 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.

Intervention: Device: Vanguard with E1 PS Bearing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: March 13, 2014)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2023
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02088372
Other Study ID Numbers INT.CR.GK4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Zimmer Biomet
Study Sponsor Zimmer Biomet
Collaborators Not Provided
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
PRS Account Zimmer Biomet
Verification Date September 2020