Back to resultsPreoperative Alignment of Total Knee Replacement
Primary Purpose
Knee Arthritis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
trumatch group
control group
Sponsored by
About this trial
This is an interventional treatment trial for Knee Arthritis focused on measuring alignment
Eligibility Criteria
Inclusion Criteria:patients undergoing primary total knee replacement -
Exclusion Criteria:patients who have hardware involving the hip, knee or ankle
-
Sites / Locations
- Palo Alto VA HCS
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control group
trumatch group
Arm Description
control group will have standard instrumentation of their knee replacement
the trumatch patient will have custom instruments made from preop CT scans
Outcomes
Primary Outcome Measures
Alignment of Knee - Measured Mechanical Axis From CT Data
the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment
Secondary Outcome Measures
Surgical Time
the difference between the average surgical time will be determined and compared with 95% CI
Full Information
NCT ID
NCT01242085
First Posted
November 15, 2010
Last Updated
May 9, 2013
Sponsor
VA Palo Alto Health Care System
Collaborators
DePuy Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT01242085
Brief Title
Preoperative Alignment of Total Knee Replacement
Official Title
Alignment of Total Knee Components Using Standard or Custom Instrumentation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System
Collaborators
DePuy Orthopaedics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthritis
Keywords
alignment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Description
control group will have standard instrumentation of their knee replacement
Arm Title
trumatch group
Arm Type
Experimental
Arm Description
the trumatch patient will have custom instruments made from preop CT scans
Intervention Type
Procedure
Intervention Name(s)
trumatch group
Other Intervention Name(s)
trumatch CPI
Intervention Description
these patient will have CT based customized knee instruments used for surgery
Intervention Type
Procedure
Intervention Name(s)
control group
Other Intervention Name(s)
Depuy knee instruments
Intervention Description
these patients will have standard instrumentation used for for knee replacement
Primary Outcome Measure Information:
Title
Alignment of Knee - Measured Mechanical Axis From CT Data
Description
the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment
Time Frame
postoperatively - CT done within 1 week of surgery
Secondary Outcome Measure Information:
Title
Surgical Time
Description
the difference between the average surgical time will be determined and compared with 95% CI
Time Frame
intraoperative surgical time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:patients undergoing primary total knee replacement -
Exclusion Criteria:patients who have hardware involving the hip, knee or ankle
-
Facility Information:
Facility Name
Palo Alto VA HCS
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Preoperative Alignment of Total Knee Replacement
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