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| ID | Type | Description | Link |
|---|---|---|---|
| NCT01064063 | Registry Identifier | Clinicaltrials.gov |
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| Name | Class |
|---|---|
| East Sussex Hospitals NHS Trust | OTHER |
| Biomet U.K. Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGC knee | 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. |
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| Vanguard CR | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| American Knee Society Knee Score | Objective scoring system to rate the knee and patient's functional abilities before and after TKA | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 year |
| American Knee Society Score, Oxford Knee-12, SF-12 |
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Inclusion Criteria:
Pre-op knee score of <70
Scheduled to undergo primary total knee replacement with any of the following indication:
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:
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| Name | Affiliation | Role |
|---|---|---|
| A. Butler-Manual, FRCS | East Sussex Hospital NHS Trust - Conquest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Sussex Hospital NHS Trust | Saint Leonards-on-Sea | East Sussex | TN37 7RD | United Kingdom |
To be confirmed.
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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).
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| AGC knee | Device | The AGC knee is a metal and polyethylene total condylar knee system offering complete component interchangeability. |
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Objective scoring instruments to rate the knee and patient's functional abilities before and after TKA including scoring systems based on patient questionnaires |
| 6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y |
| Radiographic evaluation | Assessment of patient x-rays | 6m,1y, 2y, 3y, 5y, 10y |
| Adverse Events | 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. | any |
| Survivorship | Implant survivorship based on removal of a study device. | 10 years |
| Noble & Weiss Knee Score, Kujala Score | Scoring systems based on patient questionnaires | 6w, 6m, 1y, 2y |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |