A Clinical Investigation of the Vanguard™ Complete Knee System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

552 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-31

Study Completion Date

2024-03-31

Brief Summary

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The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System.

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Detailed Description

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This is a 10-year prospective observational data collection on the Vanguard Total Knee system. Patients are asked to come in for a preop, operative, immediate post-operative, 6 Month, 1 Year, 3 Year,5 Year, 7 year, and 10 year visits to check on the function, range of motion, and radiographic assessment of their total knee device.

The Vanguard Knee is an FDA cleared device, and has been on the market since 2004.

Conditions

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Osteoarthritis Traumatic Arthritis Rheumatoid Arthritis Lower Limb Deformity Complications, Arthroplasty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vanguard™ Complete Knee System

Vanguard Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)

Vanguard™ Complete Knee System

Intervention Type DEVICE

Primary Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)

Vanguard™ Patient-Specific Femur

Vanguard Total Knee System used in combination with Signature technique to provide a patient-specific femur

Vanguard™ Patient-Specific Femur

Intervention Type DEVICE

Primary Total Knee System used with Signature technique to provide a patient-specific femur

Interventions

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Vanguard™ Complete Knee System

Primary Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)

Intervention Type DEVICE

Vanguard™ Patient-Specific Femur

Primary Total Knee System used with Signature technique to provide a patient-specific femur

Intervention Type DEVICE

Other Intervention Names

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Vanguard Select

Eligibility Criteria

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Inclusion Criteria

* 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
* Good nutritional state of the patient
* Patient must have reached full skeletal maturity

Exclusion Criteria

Absolute contraindications include:

* Infection
* Sepsis
* Osteomyelitis
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No