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

Smith & Nephew

Status and phase

Terminated

Phase 3

Conditions

Osteoarthritis of the Knee

Treatments

Procedure: Standard surgical technique

Procedure: Visionaire

Study type

Interventional

Funder types

Industry

Identifiers

NCT01224522

R11025-2

Details and patient eligibility

About

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)

Full 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

Enrollment

70 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No 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.