Signature Personalised Patient Care System With the Vanguard Knee System Study

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01092312
• Other study ID #: GBMET.CR.G4
• Status: Terminated
• Phase: N/A
• First received: March 7, 2010
• Last updated: August 31, 2017
• Start date: March 2010
• Est. completion date: September 2016

Study information

• Verified date: August 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 325
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Procedure:
• Vanguard Knee System with Signature Knee Guide
Use of Signature Knee Guide
• Vanguard Knee System with conventional Instruments
Vanguard Knee System with conventional Instruments

Locations

Country	Name	City	State
Australia	The Queen Elizabeth Hospital	Adelaide	South Australia
Australia	Logan Hospital	Brisbane	Queensland
Austria	General Hospital Kreuzschwestern	Grieskirchen	Wels
Austria	The Orthopaedic Hospital Speising	Vienna
Belgium	St Luc General Hospital	Brussels
Denmark	Aalborg University Hospital	Aalborg
France	Medipole de Savoie	Chambery
Netherlands	Amphia Ziekenhuis Breda	Breda
Portugal	Torres Verdras Hospital	Torres Vedras	Lisbon
Sweden	Danderyd Hospital	Stockholm
United Kingdom	Addenbrooke's Hospital	Cambridge
United States	Insall Scott Kelly Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Denmark,  France,  Netherlands,  Portugal,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical Axial Alignment	Femoral and tibial component alignment, femoral and tibial rotational alignment, tibial posterior slope	Prior to Discharge: 0-2 weeks
Secondary	Clinical Outcome	American Knee Society Score, Oxford Knee Score	6 months, 1 year