Status:
COMPLETED
A Clinical Investigation of the Vanguard™ Complete Knee System
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Traumatic Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
552 Patients enrolled
Trial Details
Trial ID
NCT00698854
Start Date
March 1 2004
End Date
March 1 2024
Last Update
September 19 2024
Active Locations (8)
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1
Physicians Clinic of Iowa Orthopedics
Cedar Rapids, Iowa, United States, 52403
2
The Orthopaedic Center
Rockville, Maryland, United States, 20850
3
Advanced Orthopedic Specialists
Cape Girardeau, Missouri, United States, 63701
4
Orthopaedic Associates of Rochester
Rochester, New York, United States, 14626