Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants

Zimmer Biomet1 site in 1 country150 target enrollmentFebruary 15, 2011

ConditionsOsteoarthritis Rheumatoid Arthritis Traumatic Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Zimmer Biomet
Enrollment: 150
Locations: 1
Primary Endpoint: American Knee Society Knee Score
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This evaluation is being conducted on the relative new knee system, the Vanguard Cruciate Retaining (CR) to evaluate clinical efficacy of the Vanguard CR components.

Detailed Description

This clinical trial was initially designed as a multi-centre, randomized controlled study, comparing the Vanguard CR with the AGC in routine use. The study now is a single centre study. The Vanguard CR system has been specifically designed to give greater knee stability through the use of more anatomic patello-femoral kinematics.

Registry

clinicaltrials.gov

Start Date

February 15, 2011

End Date

May 10, 2022

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zimmer Biomet

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Pre-op knee score of \<70
•Scheduled to undergo primary total knee replacement with any of the following indication:
•pain and disabled knee joint resulting from Osteoarthritis, Rheumatoid Arthritis, or Traumatic arthritis.
•One or more compartments involved.
•Need to obtain pain relief and improve function
•Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations
•A good nutritional state of the patient
•Full skeletal maturity of the patient, patients who are at least 18 years of age.
•Patients of either sex
•Consent form read, understood, and signed by patient

Exclusion Criteria

•Pre-op knee score greater than or equal to 70
•Infection
•Osteomyelitis
•Previous partial or total prosthetic knee replacement on the operative side
•Skeletal immaturity of the patient, patients who are less than 18 years of age.
•Uncooperative patient or patient with neurological disorders who are incapable of following directions
•Osteomalacia
•Distant foci of infections
•Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
•Vascular insufficiency, muscular atrophy, or neuromuscular disease in affected limb

Outcomes

Primary Outcomes

American Knee Society Knee Score

Time Frame: 2 year

Objective scoring system to rate the knee and patient's functional abilities before and after TKA

Secondary Outcomes

Survivorship(10 years)
American Knee Society Score, Oxford Knee-12, SF-12(6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y)
Patient success(2 year)
Noble & Weiss Knee Score, Kujala Score(6w, 6m, 1y, 2y)
Radiographic evaluation(6m,1y, 2y, 3y, 5y, 10y)
Adverse Events(any)