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This study has been withdrawn prior to enrollment.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

June 2, 2010
December 5, 2011
September 2010
September 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01308515 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study
A Comparative Clinical Evaluation of the Vanguard Knee System's Anterior Stabilized & Posterior Stabilized Tibial Bearings

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Osteoarthritis
  • Degenerative Arthritis
  • 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.
  • 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.
  • Posterior Stabilized
    Patients who received a PS (Posterior Stabilized) Tibial Bearing.
    Intervention: Device: Vanguard Knee System with PS Bearing
  • Anterior Stablized
    Patients who received an AS (Anterior Stabilized) Tibial Bearing
    Intervention: Device: Vanguard Knee System with AS Bearing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01308515
090809
No
Biomet, Inc.
Biomet, Inc.
Not Provided
Study Director: Ken Beres, MD Biomet (no investigators were selected for this study)
Biomet, Inc.
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP