Navigated EM Total Knee Replacement: Accuracy Study

This study has been terminated.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00512421
First received: August 5, 2007
Last updated: September 15, 2011
Last verified: August 2011

August 5, 2007
September 15, 2011
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Complete list of historical versions of study NCT00512421 on ClinicalTrials.gov Archive Site
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Navigated EM Total Knee Replacement: Accuracy Study
Phase 2 Study of Computer Assisted Surgery vs Conservative Surgery- Accuracy Study.

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

men and women that are candidates for total knee replacement.

Total Knee Replacement
Procedure: computer-assisted surgery
  • A
    navigation technique
    Intervention: Procedure: computer-assisted surgery
  • B
    conservative surgery
    Intervention: Procedure: computer-assisted surgery
  • C
    Historical control
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
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Inclusion Criteria:

  • Signing informed consent

Exclusion Criteria:

  • Pregnancy
  • Soldiers in active military service
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00512421
LIB002-HMO-CTIL
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Hadassah Medical Organization
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Principal Investigator: Meir Libergall, Prof. Hadassah Medical Organization
Hadassah Medical Organization
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP