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

Rheumatoid Arthritis Clinical Trial

Official title:

A Prospective Controlled Multi-center Study on Vanguard Complete Knee and Vanguard High Flex RP Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010269
• Other study ID #: INT.CR.RROW1
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: October 2017

Study information

• Verified date: June 2018
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2017
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Rheumatoid Arthritis
• Traumatic Arthritis

Intervention

Device:
• Vanguard Complete Knee
Vanguard Knee is a metal and polyethylene system indicated for cemented tibial and femoral use.
• Vanguard High Flex RP
Vanguard High Flex RP is an extension to the existing Vanguard Knee and has been specifically designed to facilitate greater than 135 degrees of knee flexion.

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Knee Society Knee Score	Including ROM	1 Year postop
Secondary	Kinematic Fluoroscopic Analysis	Kinematic Fluoroscopic Analysis	3 yr
Secondary	Gait Lab Analysis	Gait Lab Analysis	3 yr
Secondary	EQ5D	Quality of Life	3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr
Secondary	Radiographic Assessment	Radiographic Assessment	immediate postop, 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr