VGASPS: Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study

Sponsor

Zimmer Biomet (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01308515

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Osteoarthritis Degenerative Arthritis	Device: Vanguard Knee System with AS Bearing Device: Vanguard Knee System with PS Bearing	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

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

Study Start Date :

Sep 1, 2010

Anticipated Primary Completion Date :

Sep 1, 2010

Anticipated Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

Objective Knee Score [1 Year Post-op]
Average objective knee score; includes a combination of range of motion and pain scores.

Secondary Outcome Measures

Knee Society Score [3 Years]
Average total knee score. Includes the objective and functional aspects of the knee score.
Dislocation [3 Years]
Rate of Dislocation as reported by patients in a complication.
Survivorship [3 Years]
Reports surivival of implant.
Reports of Radiographic Loosening via Complication Form [3 Years]
A more specific survivorship element; will indicate rate of loosening if it occurs.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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