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NCT02429245 Clinical Trial

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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02429245
Other study ID # 2014-62
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 2, 2015
Last updated April 28, 2015
Start date May 2015
Est. completion date April 2016

Study information
Verified date April 2015
Source University Hospital, Strasbourg, France
Contact Jean-Yves JENNY, MD
Phone 33.3.88.55.21.45
Email jean-yves.jenny@chru-strasbourg.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• Retrospective study

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in the quality of life of patients after Knee replacement every 3 months over a period of one year No
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