Osteoarthritis, KneeFP-KneeNCT05380206
Functional Knee Phenotypes of Patients Operated on for Total Knee Arthroplasty
An observational study of Osteoarthritis, Knee, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The aim of this study was to analyze the coronal alignment of a large population of patients undergoing total knee arthroplasty using a modern classification of the knee phenotypes found in a population of non-osteoarthritic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2021to 15 Sep 2022
- 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
- Adult, Older adult
Study population: Patient aged ≥ 18 years operated between 01/01/2011 to 02/28/2021 by two experienced surgeons of a total knee prosthesis using a navigation system without image (OrthoPilot ®, Aesculap, Tuttlingen, FRG) allowing to measure during the intervention the anatomical parameters of the subject before implantation;
Who may be able to join
- Patient aged ≥ 18 years
- Patient operated between 01/01/2011 to 02/28/2021 by two experienced surgeons of a total knee prosthesis using a navigation system without image (OrthoPilot ®, Aesculap, Tuttlingen, FRG) allowing to measure during the intervention the anatomical parameters of the subject before implantation;
- Records including a complete intraoperative anatomical analysis;
- Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research.
Who cannot join
- Subject who expressed their opposition to participating in the study
- Impossibility of giving the subject informed information (difficulties in understanding the subject, etc.)
- Incomplete or absent anatomical analysis
- Subject under guardianship, curatorship or safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Orthopédique Pédiatrique - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Official title: Functional Knee Phenotypes of Patients Operated on for Total Knee Arthroplasty. Comparison With a Reference Non Arthritic Population
The aim of this study was to analyze the coronal alignment of a large population of patients undergoing total knee arthroplasty using a modern classification of the knee phenotypes found in a population of non-osteoarthritic patients.
Read the detailed description
Methods Five hundred and four navigated total knee arthroplasties will be analyzed. The following angles will be measured with a computer image free navigation system: medial femorotibial mechanical angle without stress and with maximum manual stress to reduce deformation, and medial distal femoral mechanical angle. The native medial distal femoral and medial proximal tibial angles will be calculated. The data will be analyzed as numerical and categorical data. These data will be then compared with those published in a non-arthritic population, considered as a control group.
The main criterion will be the percentage of subjects with normal overall coronal alignment, defined by the association of a normal native medial distal femoral angle and a normal native medial proximal tibial angle. The secondary criteria will be the percentages of subjects with normal medial femorotibial mechanical angle, normal native medial distal femoral angle and normal native medial proximal tibial angle. The influence of gender on primary and secondary criteria in the study group will be analyzed. The most frequent phenotypes in the study group will be identified.
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee, Osteoarthritis, Knee osteoarthritis, knee arthroplasty, Total knee arthroplasty, Navigated implantation
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with normal overall coronal alignment, defined by the association of a normal native medial distal femoral angle and a normal native medial proximal tibial angle
Measured: Files analysed retrospectively from January 01, 2011 to February 28, 2021 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start15 Mar 2021
- Primary completion15 Jul 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 500 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, PhD, Principal investigator, Service de Chirurgie Orthopédique Pédiatrique - CHU de Strasbourg - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380206
- Sponsor's protocol ID
- 8193
- Acronym
- FP-Knee
- Status last verified
- Dec 2023
- First submitted
- 12 May 2022
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Knee Phenotypes of Patients Operated on for Total Knee Arthroplasty. Comparison With a Reference Non Arthritic Population
- ClinicalTrials.gov ID
- NCT05380206
- Acronym / sponsor ID
- FP-Knee / 8193
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee, Osteoarthritis, Knee osteoarthritis, knee arthroplasty, Total knee arthroplasty, Navigated implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 18 May 2022 (actual)
- 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 aim of this study was to analyze the coronal alignment of a large population of patients undergoing total knee arthroplasty using a modern classification of the knee phenotypes found in a population of non-osteoarthritic patients.
Detailed description
Methods Five hundred and four navigated total knee arthroplasties will be analyzed. The following angles will be measured with a computer image free navigation system: medial femorotibial mechanical angle without stress and with maximum manual stress to reduce deformation, and medial distal femoral mechanical angle. The native medial distal femoral and medial proximal tibial angles will be calculated. The data will be analyzed as numerical and categorical data. These data will be then compared with those published in a non-arthritic population, considered as a control group.
The main criterion will be the percentage of subjects with normal overall coronal alignment, defined by the association of a normal native medial distal femoral angle and a normal native medial proximal tibial angle. The secondary criteria will be the percentages of subjects with normal medial femorotibial mechanical angle, normal native medial distal femoral angle and normal native medial proximal tibial angle. The influence of gender on primary and secondary criteria in the study group will be analyzed. The most frequent phenotypes in the study group will be identified.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient aged ≥ 18 years operated between 01/01/2011 to 02/28/2021 by two experienced surgeons of a total knee prosthesis using a navigation system without image (OrthoPilot ®, Aesculap, Tuttlingen, FRG) allowing to measure during the intervention the anatomical parameters of the subject before implantation;
Key inclusion criteria (4 listed)
- Patient aged ≥ 18 years
- Patient operated between 01/01/2011 to 02/28/2021 by two experienced surgeons of a total knee prosthesis using a navigation system without image (OrthoPilot ®, Aesculap, Tuttlingen, FRG) allowing to measure during the intervention the anatomical parameters of the subject before implantation;
- Records including a complete intraoperative anatomical analysis;
- Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research.
Key exclusion criteria (4 listed)
- Subject who expressed their opposition to participating in the study
- Impossibility of giving the subject informed information (difficulties in understanding the subject, etc.)
- Incomplete or absent anatomical analysis
- Subject under guardianship, curatorship or safeguard of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of subjects with normal overall coronal alignment, defined by the association of a normal native medial distal femoral angle and a normal native medial proximal tibial angle
Time frame: Files analysed retrospectively from January 01, 2011 to February 28, 2021 will be examined]
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 15 Dec 2023.
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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, PhD principal investigator
Service de Chirurgie Orthopédique Pédiatrique - CHU de Strasbourg - France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by University Hospital, Strasbourg, France at 1 site in 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 4 inclusion and 4 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 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Percentage of subjects with normal overall coronal alignment, defined by the association of a normal native medial distal femoral angle and a normal native medial proximal tibial angle (time frame: Files analysed retrospectively from January 01, 2011 to February 28, 2021 will be examined]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2023.