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Navigated EM Total Knee Replacement: Accuracy Study

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00512421
First Posted: August 7, 2007
Last Update Posted: September 16, 2011
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.
Information provided by:
Hadassah Medical Organization
  Purpose

The use of computer-assisted surgery by orthopedic surgeons experienced in the performance of total knee arthroplasty may result in better overall limb and implant alignment and fewer outliers as compared with the findings after manual total knee arthroplasty.

The alignment results in previous studies were based on radiographic measurements. The sensitivity of radiographic assessment of limb and implant alignment may not be significant enough to distinguish small differences between computer-assisted surgery and manual techniques.

It is possible that alignment differences that were too minor to be exposed on standard radiographs might result in long-term differences in the durability of arthroplasties performed with use of computer-assisted surgery or manual techniques.

Moreover it is possible to measure additional implant positioning parameters with computed tomography (CT) technology.

In this study, the investigators would like to add new method, for accurate measurement of implant alignment and to correlate its results with clinical data.


Condition Intervention
Total Knee Replacement Procedure: computer-assisted surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 2 Study of Computer Assisted Surgery vs Conservative Surgery- Accuracy Study.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 200
Groups/Cohorts Assigned Interventions
A
navigation technique
Procedure: computer-assisted surgery
B
conservative surgery
Procedure: computer-assisted surgery
C
Historical control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
men and women that are candidates for total knee replacement.
Criteria

Inclusion Criteria:

  • Signing informed consent

Exclusion Criteria:

  • Pregnancy
  • Soldiers in active military service
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512421


Locations
Israel
Hadassah Orthopedic Department
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Meir Libergall, Prof. Hadassah Medical Organization
  More Information

ClinicalTrials.gov Identifier: NCT00512421     History of Changes
Other Study ID Numbers: LIB002-HMO-CTIL
First Submitted: August 5, 2007
First Posted: August 7, 2007
Last Update Posted: September 16, 2011
Last Verified: August 2011