Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis
Intervention: Vanguard Complete Knee System w/ std tray (Device); Vanguard High Flex RP (Device)
Phase: N/A
Status: Recruiting
Sponsored by: Biomet, Inc. Official(s) and/or principal investigator(s):
Myung-Chul Lee, M.D., Ph.D., Principal Investigator, Affiliation: Seoul National University Hospital
Chul-Won Ha, M.D., Ph.D., Principal Investigator, Affiliation: Samsung Medical Center
Seong-Il Bin, M.D., Ph.D., Principal Investigator, Affiliation: Asan Medical Center
Yong In, M.D., Ph.D., Principal Investigator, Affiliation: Catholic University Uijungbu St. Mary's Hospital
Overall contact:
Dawn Lim, Phone: +82 2 567 8550, Email: dawn.lim@biomet.com
Summary
The purpose of this study is to compare Vanguard High Flex Rotating Platform to Vanguard
Complete Knee System in Asian population in terms of early range of motion (ROM), clinical
outcomes, and kinetic and kinematic characteristics in relation to healthy knees.
Clinical Details
Official title: A Prospective Controlled Multi-center Study on Vanguard Complete Knee and Vanguard High Flex RP Knee
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: American Knee Society Knee Score, including ROM
Secondary outcome: Kinematic Fluoroscopic AnalysisGait Lab Analysis EQ5D Radiographic Assessment
Detailed description:
The primary objectives of this clinical study include:
- Evaluate size fit and long term performance of Vanguard Complete Knee ("Fixed") System
in Asian and Latino population in comparison to competitor's similar product.
- Evaluate efficacy of Vanguard Complete Knee with Microplasty Tibial Tray.
- Compare Vanguard High Flex Rotating Platform ("High Flex") Knee System to Vanguard
Complete Knee System in Asian population in terms of:
- Early ROM
- Clinical outcomes
- Kinetic and Kinematic characteristics in relation to Healthy Knees. o
- Compare current design to new design of Vanguard High Flex Rotating Platform Knee
System in terms of :
- Early ROM
- Clinical outcomes
- Kinetic and Kinematic characteristics
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Painful and disabled knee joint resulting form 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.
- 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:
- Infection, sepsis, osteomyelitis, and failure of previous joint replacement.
- Uncooperative patient or patients 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
Locations and Contacts
Dawn Lim, Phone: +82 2 567 8550, Email: dawn.lim@biomet.com
Samsung Medical Center, Seoul, Korea, Republic of; Recruiting
Additional Information
Starting date: October 2009
Last updated: June 7, 2011
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