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

Phase 3

Terminated

• Conditions: Osteoarthritis of the Knee
• Interventions: Procedure: Visionaire; Procedure: Standard surgical technique

• Registration Number: NCT01224522
• Lead Sponsor: Smith & Nephew Orthopaedics AG

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

Study Timeline

• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Study Start: 2011-03
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Visionaire	Visionaire	the group who will be operated by the use of Visionaire patient matched cutting blocks
Standard Surgical technique	Standard surgical technique	The group who will be operated by means fo standard surgical technique

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Leicester General Hospital; 🇬🇧 Leicester, United Kingdom