Preoperative Alignment of Total Knee Replacement

May 9, 2013 updated by: steven woolson, VA Palo Alto Health Care System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

64

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Palo Alto VA HCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:patients undergoing primary total knee replacement -

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • trumatch CPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
postoperatively - CT done within 1 week of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Time
Time Frame: intraoperative surgical time
the difference between the average surgical time will be determined and compared with 95% CI
intraoperative surgical time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Palo Alto Health Care System

Collaborators

DePuy Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

November 15, 2010

First Submitted That Met QC Criteria

November 15, 2010

First Posted (Estimate)

November 16, 2010

Study Record Updates

Last Update Posted (Estimate)

May 14, 2013

Last Update Submitted That Met QC Criteria

May 9, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04061991

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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