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Completed

NCT Number: NCT01064063

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Sussex Hospital NHS Trust

Saint Leonards-on-Sea, East Sussex, TN37 7RD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Treatment and study plan

Vanguard CR

Device

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.

AGC knee

Device

The AGC knee is a metal and polyethylene total condylar knee system offering complete component interchangeability.

Primary outcomes

  1. 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

  1. Patient success

    Time frame: 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

  2. American Knee Society Score, Oxford Knee-12, SF-12

    Time frame: 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

  3. Radiographic evaluation

    Time frame: 6m,1y, 2y, 3y, 5y, 10y

    Assessment of patient x-rays

  4. Adverse Events

    Time frame: 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.

  5. Survivorship

    Time frame: 10 years

    Implant survivorship based on removal of a study device.

  6. Noble & Weiss Knee Score, Kujala Score

    Time frame: 6w, 6m, 1y, 2y

    Scoring systems based on patient questionnaires

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Collaborators

  • Biomet U.K. Ltd.
  • East Sussex Hospitals NHS Trust

Registry information

Acronym: Vanguard

Important dates

Study start
2011
Primary completion
2013
Study completion
2022
First posted
Feb 8, 2010
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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