Review on Minimally Invasive Skin Incision in Vanguard PS Artificial Knee Joint System

This study has been completed.

Sponsor:

Collaborator:

Biomet Japan, Inc.

Information provided by (Responsible Party):

Biomet, Inc.

ClinicalTrials.gov Identifier:

NCT01010828

First received: November 9, 2009

Last updated: October 15, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 9, 2009
Last Updated Date	October 15, 2012
Start Date ^ICMJE	November 2009
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 9, 2009)	Force from femoral and tibial side to retract and bring visual field into view [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01010828 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 9, 2009)	Incision length [ Time Frame: intraoperatively ] [ Designated as safety issue: No ] Visual determination of the extension and flexion gap [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Review on Minimally Invasive Skin Incision in Vanguard PS Artificial Knee Joint System
Official Title ^ICMJE	Not Provided
Brief Summary	This study will show whether Tri-Vector method can ensure more extensive visual field and conduct the precise surgery when compared with Mini Mid-Vastus method by conducting 2 types of skin incision approach, Tri-Vector for 36 patients or Mini-Mid Vastus for 36 patients in Vanguard PS artificial knee joint total replacement observational period before and during surgery.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement
Intervention ^ICMJE	Procedure: Incision technique Tri-Vector Approach retains the majority of 3 vectors of quadriceps. Procedure: Incision technique Mini Mid-Vastus Approach
Study Arm (s)	Active Comparator: Tri-Vector Approach Intervention: Procedure: Incision technique Experimental: Mini Mid-Vastus Approach Intervention: Procedure: Incision technique
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	72
Completion Date	March 2012
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: The patients who need artificial knee joint replacement in ordinary medical consultation are selected as the subjects. Exclusion Criteria: Patients with infections such as osteomyelitis, or sepsis (Because the affected part is lesioned, excellent surgical results cannot be obtained.)
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01010828
Other Study ID Numbers ^ICMJE	JP12
Has Data Monitoring Committee	No
Responsible Party	Biomet, Inc.
Study Sponsor ^ICMJE	Biomet, Inc.
Collaborators ^ICMJE	Biomet Japan, Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	Biomet, Inc.
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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