Preoperative Radiographic Evaluation of Medial Tibiofemoral Knee Osteoarthritis (RX-FTI)

June 11, 2026 updated by: Rennes University Hospital

Preoperative Radiographic Evaluation of Medial Tibiofemoral Knee Osteoarthritis: Reproducibility, Reliability and Correlation With Ligament Injury

Observational study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Major person subject to legal protection (safeguard of justice, guardianship, guardianship);
  • Person deprived of liberty;
  • Pregnant or nursing woman.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reproducibility
Time Frame: Baseline
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
Baseline
Reliability
Time Frame: Baseline
Reliability of profile radio: correlation rate between radiological and intraoperative data
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rennes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Gicquel, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2019

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 35RC18_3012_RX-FTI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthritis Knee

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings