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No difference in outcome between the two groups
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The purpose of this study is to determine whether the percentage cases which have ideal mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting blocks is higher than those without the use of Signature when measured immediately post-operatively.
The purpose of this study is to determine whether the percentage cases which have ideal mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting blocks is higher than those without the use of Signature when measured immediately post-operatively. Other outcomes will include knee assessments and patient questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Signature Knee Guide | Experimental | Vanguard Knee System with Signature Knee Guide |
|
| Conventional Approach | Active Comparator | Vanguard Complete Knee System with Conventional Approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vanguard Knee System with Signature Knee Guide | Procedure | Use of Signature Knee Guide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical Axial Alignment | Femoral and tibial component alignment, femoral and tibial rotational alignment, tibial posterior slope | Prior to Discharge: 0-2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome | American Knee Society Score, Oxford Knee Score | 6 months, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gordon Morrison, MBChB | The Queen Elizabeth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insall Scott Kelly Institute | New York | New York | 10065 | United States | ||
| Logan Hospital |
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| Vanguard Knee System with conventional Instruments | Procedure | Vanguard Knee System with conventional Instruments |
|
| Brisbane |
| Queensland |
| 4131 |
| Australia |
| The Queen Elizabeth Hospital | Adelaide | South Australia | 5011 | Australia |
| General Hospital Kreuzschwestern | Grieskirchen | Wels | Austria |
| The Orthopaedic Hospital Speising | Vienna | Austria |
| St Luc General Hospital | Brussels | Belgium |
| Aalborg University Hospital | Aalborg | Denmark |
| Medipole de Savoie | Chambéry | France |
| Amphia Ziekenhuis Breda | Breda | Netherlands |
| Torres Verdras Hospital | Torres Vedras | Lisbon District | Portugal |
| Danderyd Hospital | Stockholm | Sweden |
| Addenbrooke's Hospital | Cambridge | United Kingdom |