NCT02429245

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2016

Completed
Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

April 2, 2015

Last Update Submit

September 4, 2025

Conditions

Keywords

KneeKnee osteoarthritisKnee replacement

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Retrospective Studies

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Case-Control StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesCohort StudiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jean-Yves JENNY, MD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

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