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
  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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00512421     History of Changes
Other Study ID Numbers: LIB002-HMO-CTIL
Study First Received: August 5, 2007
Last Updated: September 15, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

ClinicalTrials.gov processed this record on April 17, 2014