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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This study has been withdrawn prior to enrollment.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.)
Information provided by (Responsible Party):
Zimmer Biomet Identifier:
First received: June 2, 2010
Last updated: June 19, 2017
Last verified: June 2017
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: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Clinical Evaluation of the Vanguard Knee System's Anterior Stabilized & Posterior Stabilized Tibial Bearings

Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • Objective Knee Score [ Time Frame: 1 Year Post-op ]
    Average objective knee score; includes a combination of range of motion and pain scores.

Secondary Outcome Measures:
  • Knee Society Score [ Time Frame: 3 Years ]
    Average total knee score. Includes the objective and functional aspects of the knee score.

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

  • Survivorship [ Time Frame: 3 Years ]
    Reports surivival of implant.

  • Reports of Radiographic Loosening via Complication Form [ Time Frame: 3 Years ]
    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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01308515

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

Responsible Party: Zimmer Biomet Identifier: NCT01308515     History of Changes
Other Study ID Numbers: 090809
Study First Received: June 2, 2010
Last Updated: June 19, 2017

Keywords provided by Zimmer Biomet:
knee surgery

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on August 22, 2017