Axial Alignment in Patients Operated Using the Visionaire Patient Matched Cutting Blocks (Visionaire)

April 13, 2015 updated by: Smith & Nephew Orthopaedics AG

PATIENT-MATCHED INSTRUMENTATION Versus (vs) STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION

- Title: PATIENT-MATCHED INSTRUMENTATION VS. STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION

  • Short Title: Visionaire Alignment
  • Methodology: Monocentric, Single Blinded, Randomized Controlled Trial
  • Study Duration: November 2010 to July 2014
  • Study Centres: Leicester General Hospital, United Kingdom (UK)

Study Overview

Detailed Description

Malalignment is one of the main reasons for knee arthroplasty revision. With the use of patient matched cutting block we expect better axial alignment of the components.

Research Objectives:

  • The primary research objective is to evaluate the axial alignment and component position in TKA with use of Smith & Nephew's VISIONAIRE Patient Matched Technology and to compare with the alignment when standard instrumentation.
  • Secondary research objectives include assessing the safety and effectiveness of the VISIONAIRE patient matched technology as compared to commonly accepted standard instrumentation in patients suffering from symptomatic osteoarthritis of the knee joint.

    - Outcome Measures:

  • Implant alignment and Component position by means of CT-scans
  • Knee Society Score
  • EuroQol-5 Dimensions (EQ-5D)
  • Knee injury and Osteoarthritis Outcome Score (KOOS)
  • Oxford Knee Score
  • Knee-related adverse events
  • Standard and full leg x-ray

    • Number of Subjects: 70 (2*35)
    • Enrollment time: 18 months
    • Diagnosis and Main Inclusion Criteria: Patients with osteoarthritis of the knee requiring total knee arthroplasty
    • Study Product, Dose, Route, Regimen:

VISIONAIRE patient matched technology versus the commonly accepted standard instrumentation for the Genesis II total knee arthroplasty implant

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Leicester, United Kingdom, LE5 4PW
        • Leicester General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Indication for TKA, Axial alignment between 10 degrees valgus and 20 degrees varus, BMI <36, patient must be amendable for both Genesis II total knee and Visioniare cutting blocks

Exclusion Criteria:

  • Insufficient femoral or tibia bone stock, inflammatory arthritis (e.g. rheumatoid arthritis), patient is immunosuppressed, has an active infection (local or systemic), patient has physical, emotional or neurological conditions that would compromise the patients compliance with rehabilitation and follow up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Visionaire
the group who will be operated by the use of Visionaire patient matched cutting blocks
Implantation of a Genesis II Total Knee by means of Visionaire patient matched cutting blocks.
Other Names:
  • Standard Smith & Nephew instruments
  • Visionaire Instruments
ACTIVE_COMPARATOR: Standard Surgical technique
The group who will be operated by means fo standard surgical technique
Implantation of Genesis II Total Knee system by means of standard surgical technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axial Alignment
Time Frame: 6 weeks,
Axial alignment will be measured by means of CT scan and long leg x-ray
6 weeks,

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical effectiveness and safety.
Time Frame: 1 year
Safety and effectiveness will be measured by means of Knee Society Score, Oxford Score, EQ-5D and radiographic findings
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Urjit Chatterji, MD, Leicester General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

October 14, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (ESTIMATE)

October 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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