Signature Personalised Patient Care System With the Vanguard Knee System Study

Not Applicable

Terminated

• Conditions: Arthroplasty, Replacement, Knee

• Registration Number: NCT01092312
• Lead Sponsor: Zimmer Biomet

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-07
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-24
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 325

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mechanical Axial Alignment	Prior to Discharge: 0-2 weeks	Femoral and tibial component alignment, femoral and tibial rotational alignment, tibial posterior slope

Secondary Outcome Measures

Name	Time	Method
Clinical Outcome	6 months, 1 year	American Knee Society Score, Oxford Knee Score

Trial Locations

Locations (12)

Insall Scott Kelly Institute; 🇺🇸 New York, New York, United States

Logan Hospital; 🇦🇺 Brisbane, Queensland, Australia

The Queen Elizabeth Hospital; 🇦🇺 Adelaide, South Australia, 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; 🇫🇷 Chambery, France

Amphia Ziekenhuis Breda; 🇳🇱 Breda, Netherlands

Torres Verdras Hospital; 🇵🇹 Torres Vedras, Lisbon, Portugal

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