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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01224522

Acronym

Visionaire

Enrollment

Registered

2010-10-20

Start date

2011-03-31

Completion date

2014-08-31

Last updated

2015-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee

Keywords

Randomized Controlled Trial, Total Knee Arthroplasty, Patient Matched Cutting Blocks

Brief 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)

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

Interventions

PROCEDUREVisionaire

Implantation of a Genesis II Total Knee by means of Visionaire patient matched cutting blocks.

PROCEDUREStandard surgical technique

Implantation of Genesis II Total Knee system by means of standard surgical technique.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026