A Clinical Investigation of the Vanguard™ Complete Knee System
Completed
Conditions studied: Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Lower Limb Deformity, Complications, Arthroplasty
In brief
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System.
Key facts
- Study ID
- NCT00698854
- Run by
- Zimmer Biomet
- People needed
- 552
- Starts
- 2004-03-01
- Expected to finish
- 2024-03-01
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- Good nutritional state of the patient
- Patient must have reached full skeletal maturity
You may not qualify if…
- 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
Where it is running
- Physicians Clinic of Iowa Orthopedics — Cedar Rapids, Iowa, United States
- The Orthopaedic Center — Rockville, Maryland, United States
- Advanced Orthopedic Specialists — Cape Girardeau, Missouri, United States
- Orthopaedic Associates of Rochester — Rochester, New York, United States
- Texas Orthopedic Specialists — Grapevine, Texas, United States
- Orthopedic Associates — Fishersville, Virginia, United States
- Spokane Orthopedics — Spokane, Washington, United States
- Othopaedic & Sports Medicine Clinic of Monroe — Monroe, Wisconsin, United States
Full record on ClinicalTrials.gov
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