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

NCT ID: NCT02429245

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-01

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Retrospective study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Yves JENNY, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Strasbourg, France

References

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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.

Reference Type DERIVED
PMID: 28396050 (View on PubMed)

Other Identifiers

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2014-62

Identifier Type: -

Identifier Source: org_study_id

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