Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants (Vanguard)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01064063|
Recruitment Status : Active, not recruiting
First Posted : February 8, 2010
Last Update Posted : March 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis||Device: Vanguard CR Device: AGC knee||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomised into two arms, one receiving the AGC CR cement knee system (control group), and the other receiving Vanguard CR cement knee system (trial group).|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants|
|Actual Study Start Date :||February 15, 2011|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||June 2023|
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.
- American Knee Society Knee Score [ Time Frame: 2 year ]
- 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 ]
- Survivorship [ Time Frame: 10 years ]
- Noble & Weiss Knee Score, Kujala Score [ Time Frame: 6w, 6m, 1y, 2y ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064063
|East Sussex Hospital NHS Trust|
|St. Leonards on Sea, East Sussex, United Kingdom, TN37 7RD|
|Principal Investigator:||A. Butler-Manual, FRCS||East Sussex Hospital NHS Trust - Conquest Hospital|