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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
  Purpose
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 Intervention Phase
Knee Arthritis Procedure: trumatch group Procedure: control group Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alignment of Total Knee Components Using Standard or Custom Instrumentation

Further study details as provided by steven woolson, VA Palo Alto Health Care System:

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


Enrollment: 64
Study Start Date: November 2010
Study Completion Date: January 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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

Inclusion Criteria:patients undergoing primary total knee replacement -

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242085

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

Responsible Party: steven woolson, staff surgeon, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT01242085     History of Changes
Other Study ID Numbers: 04061991
Study First Received: November 15, 2010
Results First Received: February 19, 2013
Last Updated: May 9, 2013

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

ClinicalTrials.gov processed this record on June 22, 2017