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Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study (VGASPS)

This study has been withdrawn prior to enrollment.
(Could not find interested researchers/clinicians to complete study protocol.)
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01308515
First received: June 2, 2010
Last updated: December 5, 2011
Last verified: March 2011
History of Changes
  Purpose

The purpose of this study is to compare the performance of two FDA-cleared tibial bearings (replacement for cartilage in the knee) by collecting data on patients through 3 years of follow-up.


Condition Intervention
Osteoarthritis
Degenerative Arthritis
 Device: Vanguard Knee System with AS Bearing
Device: Vanguard Knee System with PS Bearing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative Clinical Evaluation of the Vanguard Knee System's Anterior Stabilized & Posterior Stabilized Tibial Bearings

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Objective Knee Score [ Time Frame: 1 Year Post-op ] [ Designated as safety issue: No ]
    Average objective knee score; includes a combination of range of motion and pain scores.


Secondary Outcome Measures:
  • Knee Society Score [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
    Average total knee score. Includes the objective and functional aspects of the knee score.

  • Dislocation [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
    Rate of Dislocation as reported by patients in a complication.

  • Survivorship [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
    Reports surivival of implant.

  • Reports of Radiographic Loosening via Complication Form [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
    A more specific survivorship element; will indicate rate of loosening if it occurs.


Enrollment: 0
Study Start Date: September 2010
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Posterior Stabilized
Patients who received a PS (Posterior Stabilized) Tibial Bearing.
 Device: Vanguard Knee System with PS Bearing
FDA cleared Tibial bearing that stabilizes the knee with a post that articulates with the FDA cleared Vanguard PS(Posterior Stabilizing) Femoral Component.
Anterior Stablized
Patients who received an AS (Anterior Stabilized) Tibial Bearing
 Device: Vanguard Knee System with AS Bearing
FDA cleared Tibial bearing that stabilizes the knee with an anterior lip, and is used with FDA cleared Vanguard CR (Cruciate Retaining) Femoral Component.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria are identical to the indications stated in the FDA approved labeling for the device 510(k) K023546, K033489, and K050222. These indications are stated below:

  • Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
  • Correction of varus, valgus, or posttraumatic deformity.
  • Correction or revision of unsuccessful osteotomy, or arthrodesis.

Patient selection factors to be considered include:

  • Need to obtain pain relief and improve function
  • Ability and willingness of the patient to follow instructions, including control of weight and activity level
  • A good nutritional state of the patient
  • The patient must have reached full skeletal maturity

Exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device 510(k) K023546, K033489, and K050222.

These contraindications 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308515

Sponsors and Collaborators
Biomet, Inc.
Investigators
Study Director: Ken Beres, MD Biomet (no investigators were selected for this study)
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01308515     History of Changes
Other Study ID Numbers: 090809
Study First Received: June 2, 2010
Last Updated: December 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
knee
osteoarthritis
joint
replacement
knee surgery

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013