Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study

NCT01308515 | Withdrawn

• 1 other identifier: 090809
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis; Degenerative Arthritis

Keywords

knee; osteoarthritis; joint; replacement; knee surgery

Outcome Measures

Primary Outcomes (1)

• Objective Knee Score

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

  1 Year Post-op

Secondary Outcomes (4)

• Knee Society Score

  3 Years

• Dislocation

  3 Years

• Survivorship

  3 Years

• Reports of Radiographic Loosening via Complication Form

  3 Years

Study Arms (2)

Posterior Stabilized

OTHER

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

Device: Vanguard Knee System with PS Bearing

Anterior Stablized

OTHER

Patients who received an AS (Anterior Stabilized) Tibial Bearing

Device: Vanguard Knee System with AS Bearing

Interventions

Vanguard Knee System with AS Bearing DEVICE

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

Anterior Stablized

Vanguard Knee System with PS Bearing DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ken Beres, MD

  Biomet (no investigators were selected for this study)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: March 4, 2011
• Study Start: September 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 21, 2017

Record last verified: 2017-06