Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study

Not Applicable

Completed

• Conditions: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis

• Registration Number: NCT01010269
• Lead Sponsor: Zimmer Biomet

Brief 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.

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

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-11-06
• Study First Posted: 2009-11-10
• Primary Completion: 2012-10
• Study Completion: 2017-10
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-21
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
American Knee Society Knee Score	1 Year postop	Including ROM

Secondary Outcome Measures

Name	Time	Method
Gait Lab Analysis	3 yr	Gait Lab Analysis
Kinematic Fluoroscopic Analysis	3 yr	Kinematic Fluoroscopic Analysis
EQ5D	3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr	Quality of Life
Radiographic Assessment	immediate postop, 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr	Radiographic Assessment

Trial Locations

Locations (4)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul Nat'l Uni. Hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic Uni. of Korea, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of