Arthritis KneeRX-FTINCT03704558
Preoperative Radiographic Evaluation of Medial Tibiofemoral Knee Osteoarthritis
An observational study of Arthritis Knee, run by Rennes University Hospital.
Trial summary
Observational study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis Knee
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to May 2019
- 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 who received a uni-compartmental prosthesis or a total knee replacement over a period of 6 months at the Rennes University Hospital
Who may be able to join
- Patient aged 18 years or over;
- presenting with medial femoral tibial osteoarthritis;
- Indication of a TKA or a medial PUC of first intention;
- Validation of the surgical indication at orthopedic surgery staff;
- Not having expressed his opposition to participate in the study.
Who cannot join
- Major person subject to legal protection (safeguard of justice, guardianship, guardianship);
- Person deprived of liberty;
- Pregnant or nursing woman.
About this study
Official title: Preoperative Radiographic Evaluation of Medial Tibiofemoral Knee Osteoarthritis: Reproducibility, Reliability and Correlation With Ligament Injury
Observational study.
Read the detailed description
In advanced stage osteoarthritis or osteonecrosis of the articular bearing surfaces of the knee, the surgical therapeutic solutions consist of a replacement of the articular surfaces by prosthetic implants. Depending on whether these implants replace all or part of the articular surfaces they are called "total" or "uni compartmental" knee prosthesis.
The uni-compartmental medial prosthesis replaces only the medial tibiofemoral compartment of the knee and is therefore intended for patients with cartilaginous wear isolated from this compartment.
The uni-compartmental medial prosthesis has advantages over the total knee arthroplasty of being more economical in articular tissues of the knee, having better functional results and lower complication rates. Although this is debated, the survival rate of uni-compartmental prostheses in the international registers is lower than that of total knee prostheses.
One of the most common early failure factors of uni-compartmental prostheses is the absence of a functional anterior cruciate ligament. Other factors have also been identified and are sometimes highly debated such as the Kozinn and Scott criteria. The group of designers of the unicompartmental Oxford Uni compartmental prosthesis Knee Arthroplasty (OUKA) (Zimmer Biomet, Warsaw) proposed and validated expanded criteria. These criteria, exclusively radiographic, are grouped in a document called "decision aid" to check the functional status of the collateral ligaments medial and anterior cross, other compartments of the knee (lateral femoro-tibial and femoro-patellar).
In decision aid, the functional status of the anterior cruciate ligament is judged on the knee radiograph by the location of the osteoarthritic cup. If it is present and functional, the cartilaginous wear is anterior with a respect of the posterior portion of the tibial plateau.
After regular use of the French version of the decision aid, the assessment of the location of osteoarthritis seems subjective to us however it is essential to validate the indication of a uni-compartmental prosthesis. In case of poor evaluation, the risk is the intraoperative discovery of the actual status of the anterior cruciate ligament that may result in a change of indication and the installation of a total knee prosthesis. The investigators have not found in the literature, studies evaluating the reliability and reproducibility of the lateral radiograph to judge the functional status of the anterior cruciate ligament.
The hypothesis is that the lateral radiograph is unreliable and reproducible to judge the functional status of the anterior cruciate ligament in a population of patients with medial femoro-tibial knee osteoarthritis.
- Conditions
- Arthritis Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation
Correlation rate between compliance with the posterior third of the radiologically assessed tibial plateau and the functional status of the anterior cruciate ligament
Measured: Baseline
Secondary outcomes (2)
Reproducibility
Inter and intra-observer reproducibility of the preoperative radiological analysis: size of the wear cup, distance posterior edge of the tray - cup, respect of the posterior third and functional status of the anterior cruciate ligament
Measured: Baseline
Reliability
Reliability of profile radio: correlation rate between radiological and intraoperative data
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study startNov 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Why it stopped: The project leader has left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Gicquel, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704558
- Sponsor's protocol ID
- 35RC18_3012_RX-FTI
- Acronym
- RX-FTI
- Status last verified
- Jun 2026
- First submitted
- 10 Oct 2018
- Last updated
- 12 Jun 2026
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Radiographic Evaluation of Medial Tibiofemoral Knee Osteoarthritis: Reproducibility, Reliability and Correlation With Ligament Injury
- ClinicalTrials.gov ID
- NCT03704558
- Acronym / sponsor ID
- RX-FTI / 35RC18_3012_RX-FTI
- Conditions
- Arthritis Knee
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The project leader has left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 15 Oct 2018 (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.
Observational study.
Detailed description
In advanced stage osteoarthritis or osteonecrosis of the articular bearing surfaces of the knee, the surgical therapeutic solutions consist of a replacement of the articular surfaces by prosthetic implants. Depending on whether these implants replace all or part of the articular surfaces they are called "total" or "uni compartmental" knee prosthesis.
The uni-compartmental medial prosthesis replaces only the medial tibiofemoral compartment of the knee and is therefore intended for patients with cartilaginous wear isolated from this compartment.
The uni-compartmental medial prosthesis has advantages over the total knee arthroplasty of being more economical in articular tissues of the knee, having better functional results and lower complication rates. Although this is debated, the survival rate of uni-compartmental prostheses in the international registers is lower than that of total knee prostheses.
One of the most common early failure factors of uni-compartmental prostheses is the absence of a functional anterior cruciate ligament. Other factors have also been identified and are sometimes highly debated such as the Kozinn and Scott criteria. The group of designers of the unicompartmental Oxford Uni compartmental prosthesis Knee Arthroplasty (OUKA) (Zimmer Biomet, Warsaw) proposed and validated expanded criteria. These criteria, exclusively radiographic, are grouped in a document called "decision aid" to check the functional status of the collateral ligaments medial and anterior cross, other compartments of the knee (lateral femoro-tibial and femoro-patellar).
In decision aid, the functional status of the anterior cruciate ligament is judged on the knee radiograph by the location of the osteoarthritic cup. If it is present and functional, the cartilaginous wear is anterior with a respect of the posterior portion of the tibial plateau.
After regular use of the French version of the decision aid, the assessment of the location of osteoarthritis seems subjective to us however it is essential to validate the indication of a uni-compartmental prosthesis. In case of poor evaluation, the risk is the intraoperative discovery of the actual status of the anterior cruciate ligament that may result in a change of indication and the installation of a total knee prosthesis. The investigators have not found in the literature, studies evaluating the reliability and reproducibility of the lateral radiograph to judge the functional status of the anterior cruciate ligament.
The hypothesis is that the lateral radiograph is unreliable and reproducible to judge the functional status of the anterior cruciate ligament in a population of patients with medial femoro-tibial knee osteoarthritis.
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 who received a uni-compartmental prosthesis or a total knee replacement over a period of 6 months at the Rennes University Hospital
Key inclusion criteria (5 listed)
- Patient aged 18 years or over;
- presenting with medial femoral tibial osteoarthritis;
- Indication of a TKA or a medial PUC of first intention;
- Validation of the surgical indication at orthopedic surgery staff;
- Not having expressed his opposition to participate in the study.
Key exclusion criteria (3 listed)
- Major person subject to legal protection (safeguard of justice, guardianship, guardianship);
- Person deprived of liberty;
- Pregnant or nursing woman.
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
Correlation
Time frame: Baseline
Correlation rate between compliance with the posterior third of the radiologically assessed tibial plateau and the functional status of the anterior cruciate ligament
2 secondary outcomes
Reproducibility
Time frame: Baseline
Reliability
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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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.
Thomas Gicquel principal investigator
Rennes University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis Knee, run by Rennes University Hospital.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 12 Jun 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Correlation (time frame: Baseline). 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 12 Jun 2026.