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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Smith & Nephew, Inc.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc. ( Smith & Nephew Orthopaedics AG )
ClinicalTrials.gov Identifier:
NCT01224522
First received: October 14, 2010
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

- 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)

Condition Intervention Phase
Osteoarthritis of the Knee
Procedure: Visionaire
Procedure: Standard surgical technique
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PATIENT-MATCHED INSTRUMENTATION Versus (vs) STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION

Further study details as provided by Smith & Nephew, Inc.:

Primary Outcome Measures:
  • Axial Alignment [ Time Frame: 6 weeks, ] [ Designated as safety issue: No ]
    Axial alignment will be measured by means of CT scan and long leg x-ray


Secondary Outcome Measures:
  • Clinical effectiveness and safety. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Safety and effectiveness will be measured by means of Knee Society Score, Oxford Score, EQ-5D and radiographic findings


Estimated Enrollment: 70
Study Start Date: March 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Visionaire
the group who will be operated by the use of Visionaire patient matched cutting blocks
Procedure: Visionaire
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
Procedure: Standard surgical technique
Implantation of Genesis II Total Knee system by means of standard surgical technique.
Other Name: Standard Surgical technique

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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224522

Contacts
Contact: Urjit Chatterji, MD urjit@ukgateway.net
Contact: Colin Esler, MD ce25@leicester.ac.uk

Locations
United Kingdom
Leicester General Hospital Recruiting
Leicester, United Kingdom, LE5 4PW
Principal Investigator: Urjit Chatterji, MD         
Sub-Investigator: Colin Esler, MD         
Sponsors and Collaborators
Smith & Nephew Orthopaedics AG
Investigators
Principal Investigator: Urjit Chatterji, MD Leicester General Hospital
  More Information

No publications provided

Responsible Party: Smith & Nephew, Inc. ( Smith & Nephew Orthopaedics AG )
ClinicalTrials.gov Identifier: NCT01224522     History of Changes
Other Study ID Numbers: R11025-2
Study First Received: October 14, 2010
Last Updated: February 26, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Smith & Nephew, Inc.:
Randomized Controlled Trial
Total Knee Arthroplasty
Patient Matched Cutting Blocks

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014