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Navigated EM Total Knee Replacement: Accuracy Study

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ClinicalTrials.gov Identifier: NCT00512421
Recruitment Status : Terminated
First Posted : August 7, 2007
Last Update Posted : September 16, 2011
Sponsor:
Information provided by:
Hadassah Medical Organization

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment
Total Knee Replacement Procedure: computer-assisted surgery

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 2 Study of Computer Assisted Surgery vs Conservative Surgery- Accuracy Study.

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
A
navigation technique
 Procedure: computer-assisted surgery
B
conservative surgery
 Procedure: computer-assisted surgery
C
Historical control


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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