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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis
• Intervention / Treatment: Device: AGC knee; Device: Vanguard CR

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • East Sussex
    • St. Leonards on Sea, East Sussex, United Kingdom, TN37 7RD
      • East Sussex Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: AGC knee; The AGC knee is a metal and polyethylene total condylar knee system offering complete component interchangeability.
Experimental: 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.	Device: Vanguard CR; The Vanguard CR is a metal and polyethylene total condylar knee system. The system contains three primary components: femoral, tibial, and bearing components, and a peripheral component: the patella button.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Knee Society Knee Score	Objective scoring system to rate the knee and patient's functional abilities before and after TKA	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient success	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	2 year
American Knee Society Score, Oxford Knee-12, SF-12	Objective scoring instruments to rate the knee and patient's functional abilities before and after TKA including scoring systems based on patient questionnaires	6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y
Radiographic evaluation	Assessment of patient x-rays	6m,1y, 2y, 3y, 5y, 10y
Adverse Events	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.	any
Survivorship	Implant survivorship based on removal of a study device.	10 years
Noble & Weiss Knee Score, Kujala Score	Scoring systems based on patient questionnaires	6w, 6m, 1y, 2y

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Collaborators: East Sussex Hospitals NHS Trust; Biomet U.K. Ltd.
• Investigators: Principal Investigator: A. Butler-Manual, FRCS, East Sussex Hospital NHS Trust - Conquest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2011
• Primary Completion (Actual): July 15, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: February 4, 2010
• First Submitted That Met QC Criteria: February 4, 2010
• First Posted (Estimated): February 8, 2010

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: BMETEU.CR.LEU29; NCT01064063 (Registry Identifier: Clinicaltrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To be confirmed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No