Signature Personalised Patient Care System With the Vanguard Knee System Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Biomet, Inc.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01092312
First received: March 7, 2010
Last updated: March 17, 2014
Last verified: March 2014

March 7, 2010
March 17, 2014
March 2010
May 2023   (final data collection date for primary outcome measure)
Mechanical Axial Alignment [ Time Frame: Prior to Discharge: 0-2 weeks ] [ Designated as safety issue: No ]
Femoral and tibial component alignment, femoral and tibial rotational alignment, tibial posterior slope
Same as current
Complete list of historical versions of study NCT01092312 on ClinicalTrials.gov Archive Site
Clinical Outcome [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]
American Knee Society Score, Oxford Knee Score
Same as current
Not Provided
Not Provided
 
Signature Personalised Patient Care System With the Vanguard Knee System Study
Study on the Signature Personalised Patient Care System With the Vanguard Knee System

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Arthroplasty, Replacement, Knee
  • Device: Vanguard Knee System with Signature Knee Guide
    Use of Signature Knee Guide
  • Device: Vanguard Knee System with conventional Instruments
    Use of Conventional instruments
  • Experimental: Signature Knee Guide
    Vanguard Knee System with Signature Knee Guide
    Intervention: Device: Vanguard Knee System with Signature Knee Guide
  • Active Comparator: Conventional Approach
    Vanguard Complete Knee System with Conventional Approach
    Intervention: Device: Vanguard Knee System with conventional Instruments
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
628
May 2023
May 2023   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States,   Australia,   Austria,   Belgium,   Denmark,   France,   Netherlands,   Portugal,   Sweden,   United Kingdom
 
NCT01092312
BMET AU02
No
Biomet, Inc.
Biomet, Inc.
Not Provided
Principal Investigator: Gordon Morrison, MBChB The Queen Elizabeth Hospital
Biomet, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP