Signature Personalised Patient Care System With the Vanguard Knee System Study

Stopped early · Not applicable

Conditions studied: Arthroplasty, Replacement, Knee

In brief

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.

Key facts

Study ID

NCT01092312

Run by

Zimmer Biomet

People needed

325

Starts

2010-03-01

Expected to finish

2016-09-01

Last updated by the study team

2017-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• infection
• sepsis
• osteomyelitis
• failure of a previous joint replacement

Where it is running

• 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 — 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

Full record on ClinicalTrials.gov

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