Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants
NCT ID: NCT01064063
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2011-02-15
2022-05-10
Brief Summary
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Detailed Description
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The Vanguard CR system has been specifically designed to give greater knee stability through the use of more anatomic patello-femoral kinematics.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
AGC knee
The AGC knee is a metal and polyethylene total condylar knee system offering complete component interchangeability.
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.
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.
Interventions
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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.
AGC knee
The AGC knee is a metal and polyethylene total condylar knee system offering complete component interchangeability.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
East Sussex Hospitals NHS Trust
OTHER
Biomet U.K. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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A. Butler-Manual, FRCS
Role: PRINCIPAL_INVESTIGATOR
East Sussex Hospital NHS Trust - Conquest Hospital
Locations
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East Sussex Hospital NHS Trust
Saint Leonards-on-Sea, East Sussex, United Kingdom
Countries
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Other Identifiers
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NCT01064063
Identifier Type: REGISTRY
Identifier Source: secondary_id
BMETEU.CR.LEU29
Identifier Type: -
Identifier Source: org_study_id
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