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

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ClinicalTrials.gov Identifier: NCT03304119
Recruitment Status : Completed
First Posted : October 6, 2017
Results First Posted : March 11, 2019
Last Update Posted : March 20, 2019
Sponsor:
Collaborators:
Dr Vincent Chassaing
European Clinical Trial Experts Network
Information provided by (Responsible Party):
Ramsay Générale de Santé

Brief Summary:
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.

Condition or disease
Patellar Instability Patellar Dislocation

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.

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Study Type : Observational
Actual Enrollment : 92 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Torsion of the Tibial Tuberosity, a New Factor of Patellar Instability?
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : December 30, 2016
Actual Study Completion Date : December 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dislocations

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304119


Locations
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France
ECTEN
Paris, IDF, France, 75010
Sponsors and Collaborators
Ramsay Générale de Santé
Dr Vincent Chassaing
European Clinical Trial Experts Network

Publications:
The Patellofemoral Joint - State of the Art in Evaluation and Management. ISAKOS 2014. Alberto Gobbi, Joao Espregueira-Mendes, Norima Nakamura Editors

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Responsible Party: Ramsay Générale de Santé
ClinicalTrials.gov Identifier: NCT03304119     History of Changes
Other Study ID Numbers: RGDS TTA study
First Posted: October 6, 2017    Key Record Dates
Results First Posted: March 11, 2019
Last Update Posted: March 20, 2019
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ramsay Générale de Santé:
Torsion of tibial tuberosity
Recurrent patellar dislocation
MRI Measurements
Patellar instability
Patellar dislocation
Tibial tubercle position
Tibial tubercle torsion

Additional relevant MeSH terms:
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Joint Dislocations
Torsion Abnormality
Patellar Dislocation
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Pathological Conditions, Anatomical
Knee Injuries
Leg Injuries