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

Osteoarthritis of the Knee Clinical Trial

— Visionaire  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01224522
• Other study ID #: R11025-2
• Status: Terminated
• Phase: Phase 3
• First received: October 14, 2010
• Last updated: April 13, 2015
• Start date: March 2011
• Est. completion date: August 2014

Study information

• Verified date: April 2015
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• 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)

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Procedure:
• Visionaire
Implantation of a Genesis II Total Knee by means of Visionaire patient matched cutting blocks.
• Standard surgical technique
Implantation of Genesis II Total Knee system by means of standard surgical technique.

Locations

Country	Name	City	State
United Kingdom	Leicester General Hospital	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial Alignment	Axial alignment will be measured by means of CT scan and long leg x-ray	6 weeks,
Secondary	Clinical effectiveness and safety.	Safety and effectiveness will be measured by means of Knee Society Score, Oxford Score, EQ-5D and radiographic findings	1 year