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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2017-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation

NCT00753090

Osteoarthritis

COMPLETED NA

A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

NCT01542580

Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis +3 more

ACTIVE_NOT_RECRUITING

A Clinical Investigation of the Vanguard™ Complete Knee System

NCT00698854

Osteoarthritis Traumatic Arthritis Rheumatoid Arthritis +2 more

COMPLETED

Prospective Multi-Center Study on Vanguard With E1 Bearing

NCT02088372

Varus Deformity Valgus Deformity Posttraumatic Deformity +2 more

TERMINATED

A Prospective Randomized Study on Vanguard Cruciate Retaining Versus Vanguard High Flex Posterior Stabilized Total Knee System in the Early Range of Motion

NCT00763113

Total Knee Arthroplasty

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vanguard Complete Knee

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.

Group Type ACTIVE_COMPARATOR

Vanguard Complete Knee

Intervention Type DEVICE

Vanguard Knee is a metal and polyethylene system indicated for cemented tibial and femoral use.

Vanguard High Flex RP

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.

Group Type ACTIVE_COMPARATOR

Vanguard High Flex RP

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vanguard Complete Knee

Vanguard Knee is a metal and polyethylene system indicated for cemented tibial and femoral use.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No