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Clinical Trials/NCT02429245
NCT02429245
Completed
Not Applicable

Evaluation of the Accuracy of a Single Cutting Guides System for the Installation of a Total Knee Replacement

University Hospital, Strasbourg, France0 sites20 target enrollmentMay 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
University Hospital, Strasbourg, France
Enrollment
20
Primary Endpoint
Improvement in the quality of life of patients after Knee replacement
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

The knee prosthesis is a validated treatment for end-stage of knee osteoarthritis, and this intervention usually provides a significant improvement in the quality of life of patients. However, a significant percentage of patients (up to 30%) are disappointed with the outcome of the intervention. One hypothesis that could explain these poor results might be the poor positioning of implants. Individual cutting guides are produced after a CT scan response planning carried out according to the CT scan anatomy of each patient, and subsequently adapted to its real anatomy during surgery, thus theoretically better accuracy of the implementation over conventional techniques. It has been shown in the past that the navigation has been the gold standard in measuring the three-dimensional orientation of the implants during surgery, and this system is systematically used in the service for over 10 years.

Registry
clinicaltrials.gov
Start Date
May 1, 2015
End Date
April 30, 2016
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients over 18 years
  • Patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total knee prosthesis.

Exclusion Criteria

  • Patients under 18 years

Outcomes

Primary Outcomes

Improvement in the quality of life of patients after Knee replacement

Time Frame: every 3 months over a period of one year

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