- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01224522
Axial Alignment in Patients Operated Using the Visionaire Patient Matched Cutting Blocks (Visionaire)
PATIENT-MATCHED INSTRUMENTATION Versus (vs) STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION
- 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)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Leicester, United Kingdom, LE5 4PW
- Leicester General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Visionaire
the group who will be operated by the use of Visionaire patient matched cutting blocks
|
Implantation of a Genesis II Total Knee by means of Visionaire patient matched cutting blocks.
Other Names:
|
ACTIVE_COMPARATOR: Standard Surgical technique
The group who will be operated by means fo standard surgical technique
|
Implantation of Genesis II Total Knee system by means of standard surgical technique.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Axial Alignment
Time Frame: 6 weeks,
|
Axial alignment will be measured by means of CT scan and long leg x-ray
|
6 weeks,
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical effectiveness and safety.
Time Frame: 1 year
|
Safety and effectiveness will be measured by means of Knee Society Score, Oxford Score, EQ-5D and radiographic findings
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Urjit Chatterji, MD, Leicester General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R11025-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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