Preoperative Alignment of Total Knee Replacement

This study has been completed.

Sponsor:

Collaborator:

DePuy Orthopaedics

Information provided by (Responsible Party):

steven woolson, VA Palo Alto Health Care System

ClinicalTrials.gov Identifier:

NCT01242085

First received: November 15, 2010

Last updated: May 9, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	November 15, 2010
Last Updated Date	May 9, 2013
Start Date ^ICMJE	November 2010
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 26, 2013)	Alignment of Knee - Measured Mechanical Axis From CT Data [ Time Frame: postoperatively - CT done within 1 week of surgery ] [ Designated as safety issue: No ] the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment
Original Primary Outcome Measures ^ICMJE (submitted: November 15, 2010)	alignment of knee components from CT of lower extremity [ Time Frame: immediate postop CT ] [ Designated as safety issue: No ] A postoperative CT of the total knee replacements in these 2 groups of patients will be compared.
Change History	Complete list of historical versions of study NCT01242085 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 26, 2013)	Surgical Time [ Time Frame: intraoperative surgical time ] [ Designated as safety issue: No ] the difference between the average surgical time will be determined and compared with 95% CI
Original Secondary Outcome Measures ^ICMJE (submitted: November 15, 2010)	surgical time [ Time Frame: intraoperative surgical time ] [ Designated as safety issue: No ] each group will have an average surgical time to compare
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Preoperative Alignment of Total Knee Replacement
Official Title ^ICMJE	Alignment of Total Knee Components Using Standard or Custom Instrumentation
Brief Summary	The hypothesis of this study is that total knee alignment will be improved by preoperative planning from CT scans and the production of custom instruments compared to the use of standard instruments.
Detailed Description	Patients will be randomized to have either customized knee instruments or standard generic instrumentation for primary total knee replacement. Postoperative CT scan will be used to determine alignment of each group.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Knee Arthritis
Intervention ^ICMJE	Procedure: trumatch group these patient will have CT based customized knee instruments used for surgery Other Name: trumatch CPI Procedure: control group these patients will have standard instrumentation used for for knee replacement Other Name: Depuy knee instruments
Study Arm (s)	Active Comparator: control group control group will have standard instrumentation of their knee replacement Intervention: Procedure: control group Experimental: trumatch group the trumatch patient will have custom instruments made from preop CT scans Intervention: Procedure: trumatch group
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	64
Completion Date	January 2013
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria:patients undergoing primary total knee replacement - Exclusion Criteria:patients who have hardware involving the hip, knee or ankle -
Gender	Both
Ages	18 Years to 90 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01242085
Other Study ID Numbers ^ICMJE	04061991
Has Data Monitoring Committee	No
Responsible Party	steven woolson, VA Palo Alto Health Care System
Study Sponsor ^ICMJE	VA Palo Alto Health Care System
Collaborators ^ICMJE	DePuy Orthopaedics
Investigators ^ICMJE	Not Provided
Information Provided By	VA Palo Alto Health Care System
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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