Signature Personalised Patient Care System With the Vanguard Knee System Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Other outcomes will include knee assessments and patient questionnaires.

Official Title
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Study on the Signature Personalised Patient Care System With the Vanguard Knee System

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Procedure: Vanguard Knee System with Signature Knee Guide
* Procedure: Vanguard Knee System with conventional Instruments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more of the knee compartments are involved correction of varus, valgus or posttraumatic deformity correction or revision of unsuccessful osteotomy (wedge cut from bone to improve alignment), or arthrodesis (fusion) need to obtain pain relief and improve function ability and willingness to follow instructions, including control of weight and activity level. a good nutritional state must have reached full skeletal maturity able and willing to undergo an MRI scan Exclusion Criteria: infection sepsis osteomyelitis failure of a previous joint replacement

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Signature Knee Guide<br>Vanguard Knee System with Signature Knee Guide | Procedure: Vanguard Knee System with Signature Knee Guide<br>* Use of Signature Knee Guide<br>|
| Active Comparator: Conventional Approach<br>Vanguard Complete Knee System with Conventional Approach | Procedure: Vanguard Knee System with conventional Instruments<br>* Vanguard Knee System with conventional Instruments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome | American Knee Society Score, Oxford Knee Score | 6 months, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee, arthroplasty