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NCT00512421 Clinical Trial

Navigated EM Total Knee Replacement: Accuracy Study

Total Knee Replacement Clinical Trial

Official title:
Phase 2 Study of Computer Assisted Surgery vs Conservative Surgery- Accuracy Study.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00512421
Other study ID # LIB002-HMO-CTIL
Secondary ID
Status Terminated
Phase N/A
First received August 5, 2007
Last updated September 15, 2011

Study information
Verified date August 2011
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Signing informed consent

Exclusion Criteria:

- Pregnancy

- Soldiers in active military service

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• computer-assisted surgery

Locations
Country Name City State
Israel Hadassah Orthopedic Department Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

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