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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-08-31

Brief Summary

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\- 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)

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Detailed Description

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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

Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Visionaire

the group who will be operated by the use of Visionaire patient matched cutting blocks

Group Type EXPERIMENTAL

Visionaire

Intervention Type PROCEDURE

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

Standard Surgical technique

The group who will be operated by means fo standard surgical technique

Group Type ACTIVE_COMPARATOR

Standard surgical technique

Intervention Type PROCEDURE

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

Interventions

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Visionaire

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

Intervention Type PROCEDURE

Standard surgical technique

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

Intervention Type PROCEDURE

Other Intervention Names

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Standard Smith & Nephew instruments Visionaire Instruments

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No