Preoperative Alignment of Total Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01242085
Recruitment Status : Completed
First Posted : November 16, 2010
Results First Posted : May 8, 2013
Last Update Posted : May 14, 2013
DePuy Orthopaedics
Information provided by (Responsible Party):
steven woolson, VA Palo Alto Health Care System

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.

Condition or disease Intervention/treatment Phase
Knee Arthritis Procedure: trumatch group Procedure: control group Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alignment of Total Knee Components Using Standard or Custom Instrumentation
Study Start Date : November 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : January 2013

Arm Intervention/treatment
Active Comparator: control group
control group will have standard instrumentation of their knee replacement
Procedure: control group
these patients will have standard instrumentation used for for knee replacement
Other Name: Depuy knee instruments

Experimental: trumatch group
the trumatch patient will have custom instruments made from preop CT scans
Procedure: trumatch group
these patient will have CT based customized knee instruments used for surgery
Other Name: trumatch CPI

Primary Outcome Measures :
  1. Alignment of Knee - Measured Mechanical Axis From CT Data [ Time Frame: postoperatively - CT done within 1 week of surgery ]
    the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment

Secondary Outcome Measures :
  1. Surgical Time [ Time Frame: intraoperative surgical time ]
    the difference between the average surgical time will be determined and compared with 95% CI

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:patients undergoing primary total knee replacement -

Exclusion Criteria:patients who have hardware involving the hip, knee or ankle

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01242085

United States, California
Palo Alto VA HCS
Palo Alto, California, United States, 94304
Sponsors and Collaborators
VA Palo Alto Health Care System
DePuy Orthopaedics

Responsible Party: steven woolson, staff surgeon, VA Palo Alto Health Care System Identifier: NCT01242085     History of Changes
Other Study ID Numbers: 04061991
First Posted: November 16, 2010    Key Record Dates
Results First Posted: May 8, 2013
Last Update Posted: May 14, 2013
Last Verified: May 2013

Keywords provided by steven woolson, VA Palo Alto Health Care System: