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

Zimmer Biomet

Status: Completed

Conditions: Traumatic Arthritis; Osteoarthritis; Rheumatoid Arthritis

Treatments: Device: Vanguard High Flex RP; Device: Vanguard Complete Knee

Study type: Interventional

Funder types: Industry

Identifiers

NCT01010269

INT.CR.RROW1

Details and patient eligibility

About

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.

Full 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

Enrollment: 300 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Vanguard Complete Knee

Active Comparator group

Description:

Vanguard Completed Knee with Microplasty Tibial Tray is designed to hold the tibial knee bearings in a microplsty knee procedure. The Co-Cro-Mo trays are designed with a shorter stem.

Treatment:

Device: Vanguard Complete Knee

Vanguard High Flex RP

Active Comparator group

Description:

VGRD High Flex RP knee is an extension to the exsting Vanguard Knee and has been specifically desinged to facilitate greather than 135 degrees of knee flextion as required by certain patients.

Treatment:

Device: Vanguard High Flex RP