Clinical trial NCT00698854: A Clinical Investigation of the Vanguard™ Complete Knee System
Official title: A Prospective, Non-controlled, Clinical Investigation of the Vanguard™ Complete Knee System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Traumatic Arthritis
Rheumatoid Arthritis
Lower Limb Deformity
Complications, Arthroplasty
Keywords: Total Knee Arthroplasty
Total Knee Replacement
Knee Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in need of relief from painful or disabling joint disease

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: KSS
timeFrame: 10 year
Secondary outcomes:
measure: Radiographic Information
timeFrame: 10 years
measure: Survivorship
timeFrame: 10 years
Other outcomes:
Locations:
city: Cedar Rapids
country: United States
facility: Physicians Clinic of Iowa Orthopedics
state: Iowa
city: Rockville
country: United States
facility: The Orthopaedic Center
state: Maryland
city: Cape Girardeau
country: United States
facility: Advanced Orthopedic Specialists
state: Missouri
city: Rochester
country: United States
facility: Orthopaedic Associates of Rochester
state: New York
city: Grapevine
country: United States
facility: Texas Orthopedic Specialists
state: Texas
city: Fishersville
country: United States
facility: Orthopedic Associates
state: Virginia
city: Spokane
country: United States
facility: Spokane Orthopedics
state: Washington
city: Monroe
country: United States
facility: Othopaedic & Sports Medicine Clinic of Monroe
state: Wisconsin
Study officials:
affiliation: Zimmer Biomet
name: Kacy C Arnold, RN MBA
role: STUDY_DIRECTOR
References: