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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

325

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach

9 countries

10 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.5 years study duration

Study Start

First participant enrolled

March 1, 2010

Completed

6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2010

Completed

17 days until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed

6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed

Last Updated

September 5, 2017

Status Verified

August 1, 2017

Enrollment Period

6.5 years

First QC Date

March 7, 2010

Last Update Submit

August 31, 2017

Conditions

Arthroplasty, Replacement, Knee

Keywords

kneearthroplasty

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

Clinical Outcome
6 months, 1 year

Study Arms (2)

Signature Knee Guide

EXPERIMENTAL

Vanguard Knee System with Signature Knee Guide

Procedure: Vanguard Knee System with Signature Knee Guide

Conventional Approach

ACTIVE COMPARATOR

Vanguard Complete Knee System with Conventional Approach

Procedure: Vanguard Knee System with conventional Instruments

Interventions

Vanguard Knee System with Signature Knee GuidePROCEDURE

Use of Signature Knee Guide

Signature Knee Guide

Vanguard Knee System with conventional InstrumentsPROCEDURE

Vanguard Knee System with conventional Instruments

Conventional Approach

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Zimmer Biometlead

Study Sites (12)

Insall Scott Kelly Institute

New York, New York, 10065, United States

Location

Logan Hospital

Brisbane, Queensland, 4131, Australia

Location

The Queen Elizabeth Hospital

Adelaide, South Australia, 5011, Australia

Location

General Hospital Kreuzschwestern

Grieskirchen, Wels, Austria

Location

The Orthopaedic Hospital Speising

Vienna, Austria

Location

St Luc General Hospital

Brussels, Belgium

Location

Aalborg University Hospital

Aalborg, Denmark

Location

Medipole de Savoie

Chambéry, France

Location

Amphia Ziekenhuis Breda

Breda, Netherlands

Location

Torres Verdras Hospital

Torres Vedras, Lisbon District, Portugal

Location

Danderyd Hospital

Stockholm, Sweden

Location

Addenbrooke's Hospital

Cambridge, United Kingdom

Location

Study Officials

Gordon Morrison, MBChB
The Queen Elizabeth Hospital
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 7, 2010

First Posted

March 24, 2010

Study Start

March 1, 2010

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 5, 2017

Record last verified: 2017-08

Locations

US(1)DK(1)FR(1)AU(2)NL(1)SE(1)GB(1)PT(1)BE(1)

Study Stopped

Signature Personalised Patient Care System With the Vanguard Knee System Study

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Signature Knee Guide

Conventional Approach

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (12)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Signature Knee Guide

Conventional Approach

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (12)

Study Officials

Study Design

Study Record Dates

Locations