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Signature Personalised Patient Care System With the Vanguard Knee System Study

Zimmer Biomet logo

Zimmer Biomet

Status

Terminated

Conditions

Arthroplasty, Replacement, Knee

Treatments

Procedure: Vanguard Knee System with conventional Instruments
Procedure: Vanguard Knee System with Signature Knee Guide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01092312
GBMET.CR.G4

Details and patient eligibility

About

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.

Full 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.

Enrollment

325 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

325 participants in 2 patient groups

Signature Knee Guide
Experimental group
Description:
Vanguard Knee System with Signature Knee Guide
Treatment:
Procedure: Vanguard Knee System with Signature Knee Guide
Conventional Approach
Active Comparator group
Description:
Vanguard Complete Knee System with Conventional Approach
Treatment:
Procedure: Vanguard Knee System with conventional Instruments

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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