Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants
This trial is active, not recruiting.
|Conditions||osteoarthritis, rheumatoid arthritis, traumatic arthritis|
|Treatments||vanguard cr, agc knee|
|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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
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
time frame: 6m,1y, 2y, 3y, 5y, 10y
time frame: any
time frame: 10 years
Noble & Weiss Knee Score, Kujala Score
time frame: 6w, 6m, 1y, 2y
Male or female participants at least 18 years old.
- 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
- Pre-op knee score greater than or equal to 70
- 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.
- Uncooperative patient or patient with neurological disorders who are incapable of following directions
- 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
|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.|
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