A Clinical Investigation of the Vanguard™ Complete Knee System



Status:Enrolling by invitation
Conditions:Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:9/9/2018
Start Date:March 2004
End Date:January 2026

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A Prospective, Non-controlled, Clinical Investigation of the Vanguard™ Complete Knee System

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

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.

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

Additional exclusion criteria includes: failure of a previous joint replacement
We found this trial at
8
sites
220 East Rowan Avenue
Spokane, Washington 99207
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Spokane, WA
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48 Doctors Park
Cape Girardeau, Missouri 63701
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Cape Girardeau, MO
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202 10th Street Southeast
Cedar Rapids, Iowa 52403
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Cedar Rapids, IA
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70 Medical Center Circle
Fishersville, Virginia 22939
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Fishersville, VA
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2425 Highway 121
Grapevine, Texas 76015
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Grapevine, TX
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1905 5th Street
Monroe, Wisconsin 53566
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Monroe, WI
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2410 Ridgeway Avenue
Rochester, New York 14626
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Rochester, NY
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Rockville, Maryland 20850
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Rockville, MD
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