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
|
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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 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. |

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

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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 |
Inclusion Criteria:
- Signing informed consent
Exclusion Criteria:
- Pregnancy
- Soldiers in active military service

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
Israel | |
Hadassah Orthopedic Department | |
Jerusalem, Israel |
Principal Investigator: | Meir Libergall, Prof. | Hadassah Medical Organization |
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 |