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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00698854
Other study ID # ORTHO.CR.K005
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 2004
Est. completion date January 2026

Study information

Verified date August 2023
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 600
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Vanguard™ Complete Knee System
Primary Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)
Vanguard™ Patient-Specific Femur
Primary Total Knee System used with Signature technique to provide a patient-specific femur

Locations

Country Name City State
United States Advanced Orthopedic Specialists Cape Girardeau Missouri
United States Physicians Clinic of Iowa Orthopedics Cedar Rapids Iowa
United States Orthopedic Associates Fishersville Virginia
United States Texas Orthopedic Specialists Grapevine Texas
United States Othopaedic & Sports Medicine Clinic of Monroe Monroe Wisconsin
United States Orthopaedic Associates of Rochester Rochester New York
United States The Orthopaedic Center Rockville Maryland
United States Spokane Orthopedics Spokane Washington

Sponsors (1)

Lead Sponsor Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary KSS Knee Society Score Assessment 10 year
Secondary Radiographic Information Radiographic Evaluation Report 10 years
Secondary Survivorship Knee Society Score Assessment 10 years
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