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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

November 15, 2010
May 9, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
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
surgical time [ Time Frame: intraoperative surgical time ] [ Designated as safety issue: No ]
each group will have an average surgical time to compare
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
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

-

Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01242085
04061991
No
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