Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study

Osteoarthritis Clinical Trial

— VGASPS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01308515
• Other study ID #: 090809
• Status: Withdrawn
• Phase: N/A
• First received: June 2, 2010
• Last updated: June 19, 2017
• Start date: September 2010
• Est. completion date: September 2010

Study information

• Verified date: June 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Arthritis
• Osteoarthritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Knee Score	Average objective knee score; includes a combination of range of motion and pain scores.	1 Year Post-op
Secondary	Knee Society Score	Average total knee score. Includes the objective and functional aspects of the knee score.	3 Years
Secondary	Dislocation	Rate of Dislocation as reported by patients in a complication.	3 Years
Secondary	Survivorship	Reports surivival of implant.	3 Years
Secondary	Reports of Radiographic Loosening via Complication Form	A more specific survivorship element; will indicate rate of loosening if it occurs.	3 Years