Torsion of the Tibial Tuberosity, a New Factor of Patellar Instability?

March 11, 2019 updated by: Ramsay Générale de Santé
Patellar instability (recurrent patellar dislocation) can occur at any age. It is most often seen in young subjects, especially among adolescents. It is commonly accompanied by anatomical factors. A new factor not described in bibliographic sources and characterized by an external torsion of the tibial tuberosity is frequently found in patients with patellar instability thanks to MRIs. This does not seem to be the case when there is no patellar pathology. A statistical study is needed to assess this rotary anomaly. Validate the predictive benefits when measuring the torsion of tibial tuberosity in cases with recurrent patellar dislocation.

Study Overview

Status

Completed

Conditions

Detailed Description

Patellar instability (recurrent patellar dislocation) can occur at any age. It is most often seen in young subjects, especially among adolescents. It is commonly accompanied by anatomical factors known to be driving: Dysplasia of the trochlea, patella alta, lateralisation of the tibial tuberosity, patellar torsion and misalignment, tearing of the Medial Patello Femoral Ligament... The assessment of these factors is essential to evaluate the instability and guide the procedures of the surgical treatment. MRIs have become an important test for the analysis and measurement of these factors. A new factor not described in bibliographic sources and characterized by an external torsion of the tibial tuberosity is frequently found in patients with patellar instability thanks to MRIs. This does not seem to be the case when there is no patellar pathology. A statistical study is needed to assess this rotary anomaly. It will be necessary to take it into account in the future regarding indications and techniques for tibial tuberosity osteotomies, often used to correct patellar instability.

Study Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • IDF
      • Paris, IDF, France, 75010
        • ECTEN

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

group of patients with patellar instability stemming from a recurrent patellar dislocationand a control group that has not been checked for patellar instability.

Description

Inclusion Criteria:

  • Men or women
  • Subjects who have not expressed opposition to the use of the data for research purposes

Clinical criteria:

  • Unstable group:

    • Medical history with 2 patellar dislocations or more,
    • with or without requiring surgical treatment after an MRI Control group: Men or women over 18 years old
    • Subjects who have not expressed opposition to the use of the data for research purposes

  • Control group:

    • Patients showing meniscal injury on MRI who may or may not have been treated (meniscectomy or stitches)

Exclusion Criteria:

  • Unstable group:

    • MRI performed on one knee operated for patellar instability
    • Associated tearing of the ligament (ACL, PCL)

  • Control group:

    • Patients with a medical history of patellar pathology
    • Patients with associated ligament injury (ACL, PCL)

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patellar instability group
Group of patients with patellar instability stemming from a recurrent patellar dislocation
Control group control
Group that has not been checked for patellar instability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Existence of Tibial Tuberosity Torsion.
Time Frame: 4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.
This criteria will be considered relevant if it is associated with patellar dislocation. Existence Yes or No and measure of the torsion in degre on the IRM
4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of Patellar Tilt
Time Frame: 4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable. Unit in degre
Patellar Tilt (yes or no), based on a patient IRM. Unit in degre.
4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable. Unit in degre
Distance TT-TG Tibial Tuberosity and Trochlear Groove
Time Frame: 4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.
distance between Tibial Tuberosity and Trochlear Groove
4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.

Collaborators and Investigators

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

Sponsor

Ramsay Générale de Santé

Collaborators

European Clinical Trial Experts Network
Dr Vincent Chassaing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 1, 2016

Primary Completion (Actual)

December 30, 2016

Study Completion (Actual)

December 30, 2016

Study Registration Dates

First Submitted

September 26, 2017

First Submitted That Met QC Criteria

September 29, 2017

First Posted (Actual)

October 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGDS TTA study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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