Knee OsteoarthritisNCT02429245
Single Cutting Guides System for the Installation of a Total Knee Replacement
An observational study of Knee Osteoarthritis, run by University Hospital, Strasbourg, France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Retrospective study
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 30 Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total knee prosthesis.
Who may be able to join
- 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.
Who cannot join
- Patients under 18 years
About this study
Official title: Evaluation of the Accuracy of a Single Cutting Guides System for the Installation of a Total Knee Replacement
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Retrospective study
- Keywords
- Knee, Knee osteoarthritis, Knee replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the quality of life of patients after Knee replacement
Measured: every 3 months over a period of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study start1 May 2015
- Primary completion30 Apr 2016
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Yves JENNY, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429245
- Sponsor's protocol ID
- 2014-62
- Status last verified
- Sep 2025
- First submitted
- 2 Apr 2015
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28396050
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of a Single Cutting Guides System for the Installation of a Total Knee Replacement
- ClinicalTrials.gov ID
- NCT02429245
- Acronym / sponsor ID
- 2014-62
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee, Knee osteoarthritis, Knee replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total knee prosthesis.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective study | Other | – |
Primary outcome
Improvement in the quality of life of patients after Knee replacement
Time frame: every 3 months over a period of one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Derived from this study: PubMed 28396050De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Yves JENNY, MD principal investigator
University Hospital, Strasbourg, France
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by University Hospital, Strasbourg, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the quality of life of patients after Knee replacement (time frame: every 3 months over a period of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02429245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.