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

Primary Purpose

Osteoarthritis, Degenerative Arthritis

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Vanguard Knee System with AS Bearing

Vanguard Knee System with PS Bearing

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring knee, osteoarthritis, joint, replacement, knee surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Posterior Stabilized

Anterior Stablized

Arm Description

Patients who received a PS (Posterior Stabilized) Tibial Bearing.

Patients who received an AS (Anterior Stabilized) Tibial Bearing

Outcomes

Primary Outcome Measures

Objective Knee Score

Average objective knee score; includes a combination of range of motion and pain scores.

Secondary Outcome Measures

Knee Society Score

Average total knee score. Includes the objective and functional aspects of the knee score.

Dislocation

Rate of Dislocation as reported by patients in a complication.

Survivorship

Reports surivival of implant.

Reports of Radiographic Loosening via Complication Form

A more specific survivorship element; will indicate rate of loosening if it occurs.

Full Information

NCT ID

NCT01308515

First Posted

June 2, 2010

Last Updated

June 19, 2017

Sponsor

Zimmer Biomet

1. Study Identification

Unique Protocol Identification Number

NCT01308515

Brief Title

Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study

Acronym

VGASPS

Official Title

A Comparative Clinical Evaluation of the Vanguard Knee System's Anterior Stabilized & Posterior Stabilized Tibial Bearings

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Could not find interested researchers/clinicians to complete study protocol.

Study Start Date

September 2010 (undefined)

Primary Completion Date

September 2010 (Anticipated)

Study Completion Date

September 2010 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zimmer Biomet

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Degenerative Arthritis

Keywords

knee, osteoarthritis, joint, replacement, knee surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Posterior Stabilized

Arm Type

Other

Arm Description

Patients who received a PS (Posterior Stabilized) Tibial Bearing.

Arm Title

Anterior Stablized

Arm Type

Other

Arm Description

Patients who received an AS (Anterior Stabilized) Tibial Bearing

Intervention Type

Device

Intervention Name(s)

Vanguard Knee System with AS Bearing

Intervention Description

FDA cleared Tibial bearing that stabilizes the knee with an anterior lip, and is used with FDA cleared Vanguard CR (Cruciate Retaining) Femoral Component.

Intervention Type

Device

Intervention Name(s)

Vanguard Knee System with PS Bearing

Intervention Description

FDA cleared Tibial bearing that stabilizes the knee with a post that articulates with the FDA cleared Vanguard PS(Posterior Stabilizing) Femoral Component.

Primary Outcome Measure Information:

Title

Objective Knee Score

Description

Average objective knee score; includes a combination of range of motion and pain scores.

Time Frame

1 Year Post-op

Secondary Outcome Measure Information:

Title

Knee Society Score

Description

Average total knee score. Includes the objective and functional aspects of the knee score.

Time Frame

3 Years

Title

Dislocation

Description

Rate of Dislocation as reported by patients in a complication.

Time Frame

3 Years

Title

Survivorship

Description

Reports surivival of implant.

Time Frame

3 Years

Title

Reports of Radiographic Loosening via Complication Form

Description

A more specific survivorship element; will indicate rate of loosening if it occurs.

Time Frame

3 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ken Beres, MD

Organizational Affiliation

Biomet (no investigators were selected for this study)

Official's Role

Study Director

12. IPD Sharing Statement

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Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study

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