This trial is active, not recruiting.

Conditions osteoarthritis, rheumatoid arthritis, traumatic arthritis
Treatments vanguard cr, agc knee
Sponsor Biomet, Inc.
Collaborator Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Start date May 2011
End date February 2022
Trial size 150 participants
Trial identifier NCT01064063, BMETEU.CR.EU29


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(Active Comparator)
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.
Patients were randomised to receive a Vanguard Cruciate Retaining Knee from the Vanguard system which encompasses concepts used ing 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.

Primary Outcomes

American Knee Society Knee Score
time frame: 2 year

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants
Principal investigator A. Butler-Manual, FRCS
Description This clinical trial is designed as a multi-centre, randomized controlled study, comparing the Vanguard CR with the AGC in routine use. The Vanguard CR system has been specifically designed to give greater knee stability through the use of more anatomic patello-femoral kinematics.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Biomet, Inc..