Clinical trial NCT01224522: Axial Alignment in Patients Operated Using the Visionaire Patient Matched Cutting Blocks
Official title: PATIENT-MATCHED INSTRUMENTATION Versus (vs) STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee
Keywords: Randomized Controlled Trial
Total Knee Arthroplasty
Patient Matched Cutting Blocks
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-20
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Axial Alignment
timeFrame: 6 weeks,
Secondary outcomes:
measure: Clinical effectiveness and safety.
timeFrame: 1 year
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
Study officials:
affiliation: Leicester General Hospital
name: Urjit Chatterji, MD
role: PRINCIPAL_INVESTIGATOR
References: