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

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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

Study Description
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Brief Summary:
Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population

Condition or disease Intervention/treatment
Varus Deformity Valgus Deformity Posttraumatic Deformity Osteoarthritis, Knee Unspecified Disorder of Knee Joint Device: Vanguard with E1 PS Bearing

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 Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluate Clinical Performance of Vanguard Knee With E1 Bearing in Korean Patient Population
Study Start Date : November 2012
Actual Primary Completion Date : December 2014
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.

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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. KOOS [ Time Frame: 6 Months ]
    Knee injuries & Osteoarthritis Outcome Score

  5. KOOS [ Time Frame: 1 Year ]
    Knee injuries & Osteoarthritis Outcome Score

  6. KOOS [ Time Frame: 3 Years ]
    Knee injuries & Osteoarthritis Outcome Score

  7. KOOS [ Time Frame: 5 Years ]
    Knee injuries & Osteoarthritis Outcome Score

  8. EQ5D [ Time Frame: 6 Months ]
    standardised instrument for use as a measure of health outcome.

  9. EQ5D [ Time Frame: 1 Year ]
    standardised instrument for use as a measure of health outcome.

  10. EQ5D [ Time Frame: 3 Years ]
    standardised instrument for use as a measure of health outcome.

  11. EQ5D [ Time Frame: 5 Years ]
    standardised instrument for use as a measure of health outcome.

  12. 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.


  13. 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.


  14. 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.


  15. 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.


  16. Radiographic Assessment [ Time Frame: Immediate Post-op(2 - 4 Weeks) ]
    Radiographic Evaluation

  17. Radiographic Assessment [ Time Frame: 6 Months ]
    Radiographic Evaluation

  18. Radiographic Assessment [ Time Frame: 1 Year ]
    Radiographic Evaluation

  19. Radiographic Assessment [ Time Frame: 3 Years ]
    Radiographic Evaluation

  20. Radiographic Assessment [ Time Frame: 5 Years ]
    Radiographic Evaluation


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088372


Locations
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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, Korea, Republic of
Sponsors and Collaborators
Zimmer Biomet
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Zimmer Biomet:
Study Protocol  [PDF] February 15, 2013

More Information
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02088372    
Other Study ID Numbers: INT.CR.GK4
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Congenital Abnormalities
Osteoarthritis
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases