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

November 15, 2010
November 16, 2010
February 19, 2013
May 8, 2013
May 14, 2013
November 2010
May 2012   (Final data collection date for primary outcome measure)
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
alignment of knee components from CT of lower extremity [ Time Frame: immediate postop CT ]
A postoperative CT of the total knee replacements in these 2 groups of patients will be compared.
Complete list of historical versions of study NCT01242085 on Archive Site
Surgical Time [ Time Frame: intraoperative surgical time ]
the difference between the average surgical time will be determined and compared with 95% CI
Surgical Time [ Time Frame: intraoperative surgical time ]
each group will have an average surgical time to compare
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Preoperative Alignment of Total Knee Replacement
Alignment of Total Knee Components Using Standard or Custom Instrumentation
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.
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Knee Arthritis
  • 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
  • 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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2013
May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:patients undergoing primary total knee replacement -

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

Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
steven woolson, VA Palo Alto Health Care System
VA Palo Alto Health Care System
DePuy Orthopaedics
Not Provided
VA Palo Alto Health Care System
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP