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

Not Applicable

Completed

• Conditions: Osteoarthritis; Traumatic Arthritis; Rheumatoid Arthritis
• Interventions: Device: AGC knee; Device: Vanguard CR

• Registration Number: NCT01064063
• Lead Sponsor: Zimmer Biomet

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.

Study Timeline

• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-08
• Study Start: 2011-02-15
• Primary Completion: 2013-12-15
• Study Completion: 2022-05-10
• Status Verified: 2023-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Pre-op knee score of <70

• Scheduled to undergo primary total knee replacement with any of the following indication:

  1. pain and disabled knee joint resulting from Osteoarthritis, Rheumatoid Arthritis, or Traumatic arthritis.
  2. 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.
• Sepsis
• 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
• Incomplete or deficient soft tissue surrounding the knee

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AGC knee	AGC knee	Patients were randomised to receive an AGC Cruciate Retaining cement knee. This is the control group in the study; the AGC is the gold standard of Biomets' knee products.
Vanguard CR	Vanguard CR	Patients were randomised to receive a Vanguard Cruciate Retaining Knee from the Vanguard system which encompasses concepts used in the AGC family of knees. The Vanguard is specifically designed to give greater knees stability through use of more anatomic patello-femoral kinematics.

Primary Outcome Measures

Name	Time	Method
American Knee Society Knee Score	2 year	Objective scoring system to rate the knee and patient's functional abilities before and after TKA

Secondary Outcome Measures

Name	Time	Method
Survivorship	10 years	Implant survivorship based on removal of a study device.
American Knee Society Score, Oxford Knee-12, SF-12	6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y	Objective scoring instruments to rate the knee and patient's functional abilities before and after TKA including scoring systems based on patient questionnaires
Patient success	2 year	Defined as Knee Score greater than or equal to 80, No component revisions or removals, No pending component revisions or removals, Absence of osteolysis, No migration/subsidence of \>3mm or \>3 degrees
Noble & Weiss Knee Score, Kujala Score	6w, 6m, 1y, 2y	Scoring systems based on patient questionnaires
Radiographic evaluation	6m,1y, 2y, 3y, 5y, 10y	Assessment of patient x-rays
Adverse Events	any	Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the investigational medical device.

Trial Locations

Locations (1)

East Sussex Hospital NHS Trust; 🇬🇧 St. Leonards on Sea, East Sussex, United Kingdom