Study Stopped
protocol deviations
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
1 other identifier
interventional
70
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2011
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2010
CompletedFirst Posted
Study publicly available on registry
October 20, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedApril 14, 2015
April 1, 2015
3.4 years
October 14, 2010
April 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Axial Alignment
Axial alignment will be measured by means of CT scan and long leg x-ray
6 weeks,
Secondary Outcomes (1)
Clinical effectiveness and safety.
1 year
Study Arms (2)
Visionaire
EXPERIMENTALthe group who will be operated by the use of Visionaire patient matched cutting blocks
Standard Surgical technique
ACTIVE COMPARATORThe group who will be operated by means fo standard surgical technique
Interventions
Implantation of a Genesis II Total Knee by means of Visionaire patient matched cutting blocks.
Implantation of Genesis II Total Knee system by means of standard surgical technique.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leicester General Hospital
Leicester, LE5 4PW, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Urjit Chatterji, MD
Leicester General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2010
First Posted
October 20, 2010
Study Start
March 1, 2011
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
April 14, 2015
Record last verified: 2015-04