Single Cutting Guides System for the Installation of a Total Knee Replacement
Evaluation of the Accuracy of a Single Cutting Guides System for the Installation of a Total Knee Replacement
1 other identifier
observational
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2015
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2015
CompletedFirst Posted
Study publicly available on registry
April 29, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2016
CompletedSeptember 5, 2025
September 1, 2025
1 year
April 2, 2015
September 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in the quality of life of patients after Knee replacement
every 3 months over a period of one year
Interventions
Eligibility Criteria
Patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total knee prosthesis.
You may qualify if:
- 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.
You may not qualify if:
- Patients under 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
De Gori M, Adamczewski B, Jenny JY. Value of the cumulative sum test for the assessment of a learning curve: Application to the introduction of patient-specific instrumentation for total knee arthroplasty in an academic department. Knee. 2017 Jun;24(3):615-621. doi: 10.1016/j.knee.2017.03.007. Epub 2017 Apr 7.
PMID: 28396050DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Yves JENNY, MD
University Hospital, Strasbourg, France
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2015
First Posted
April 29, 2015
Study Start
May 1, 2015
Primary Completion
April 30, 2016
Study Completion
April 30, 2016
Last Updated
September 5, 2025
Record last verified: 2025-09