CClinicalTrials.gg
CompletedNCT03304119Updated Mar 20, 2019Results posted

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

An observational study in Patellar Instability and Patellar Dislocation, sponsored by Ramsay Générale de Santé. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2019-03-20.

Sponsored by Ramsay Générale de Santé · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
92
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Patellar Instability
  • Patellar Dislocation

Keywords

  • Torsion of tibial tuberosity
  • Recurrent patellar dislocation
  • MRI Measurements
  • Patellar instability
  • Patellar dislocation
  • Tibial tubercle position
  • Tibial tubercle torsion
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

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

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)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
92 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. Existence of Tibial Tuberosity Torsion.

    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

    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.

Secondary outcomes

  1. Measure of Patellar Tilt

    Patellar Tilt (yes or no), based on a patient IRM. Unit in degre.

    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

  2. Distance TT-TG Tibial Tuberosity and Trochlear Groove

    distance between 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.

06

Results

Posted Mar 11, 2019

Participant flow

Participant flow — Overall Study
MilestonePatellar Instability GroupControl Group Control
Started3755
Completed3755
Not completed00

Outcome measures

PrimaryExistence of Tibial Tuberosity Torsion.

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

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.
Reported as:
Median · degre
Existence of Tibial Tuberosity Torsion.
degrePatellar Instability GroupControl Group Control
Existence of Tibial Tuberosity Torsion.17.5 (13.0 to 23.9)5.3 (3.4 to 8.4)
SecondaryMeasure of Patellar Tilt

Patellar Tilt (yes or no), based on a patient IRM. Unit in degre.

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
Reported as:
Median · degre
Measure of Patellar Tilt
degrePatellar Instability GroupControl Group Control
Measure of Patellar Tilt19.8 (13.8 to 27.6)5.3 (2.5 to 8.2)
SecondaryDistance TT-TG Tibial Tuberosity and Trochlear Groove

distance between 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.
Reported as:
Median · milimeters
Distance TT-TG Tibial Tuberosity and Trochlear Groove
milimetersPatellar Instability GroupControl Group Control
Distance TT-TG Tibial Tuberosity and Trochlear Groove17 (12.2 to 20.1)8.4 (6.7 to 9.8)

Adverse events

Collected over Not Applicable. Study consist in IRM reading. NO adverse events has been collected. Not applicable, retrospective study based on available IRM. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Patellar Instability Group———
Control Group Control———

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Patellar Instability GroupControl Group ControlTotal
<=18 years112
Between 18 and 65 years365389
>=65 years011
Age, Continuous
Age, Continuous(years)Patellar Instability GroupControl Group ControlTotal
mean28.6 ± 10.746 ± 1439 ± 15.4
Sex: Female, Male
Sex: Female, Male(Participants)Patellar Instability GroupControl Group ControlTotal
Female231942
Male143650
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Patellar Instability GroupControl Group ControlTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Patellar Instability GroupControl Group ControlTotal
France375592
07

Study locations

1 site
  • ECTEN
    Paris, IDF 75010, France
08

References and documents

Publications

  • Skelley N, Friedman M, McGinnis M, Smith C, Hillen T, Matava M. Inter- and intraobserver reliability in the MRI measurement of the tibial tubercle-trochlear groove distance and trochlea dysplasia. Am J Sports Med. 2015 Apr;43(4):873-8. doi: 10.1177/0363546514565768. Epub 2015 Jan 28. PubMed 25632054 ↗
  • The Patellofemoral Joint - State of the Art in Evaluation and Management. ISAKOS 2014. Alberto Gobbi, Joao Espregueira-Mendes, Norima Nakamura Editors
  • Diederichs G, Issever AS, Scheffler S. MR imaging of patellar instability: injury patterns and assessment of risk factors. Radiographics. 2010 Jul-Aug;30(4):961-81. doi: 10.1148/rg.304095755. Erratum In: Radiographics. 2011 Mar-Apr;31(2):624. PubMed 20631363 ↗
  • Biedert RM. [Osteotomies]. Orthopade. 2008 Sep;37(9):872, 874-6, 878-80 passim. doi: 10.1007/s00132-008-1294-5. German. PubMed 18682913 ↗
  • Pache T, Meystre JL, Delgado-Martins H, Schnyder P. [Transplantation of the anterior tibial tubercle by the Elmslie-Trillat technic. Indications as a function of morphotype]. Rev Chir Orthop Reparatrice Appar Mot. 1985;71(6):359-64. French. PubMed 4081137 ↗
  • Rhee SJ, Pavlou G, Oakley J, Barlow D, Haddad F. Modern management of patellar instability. Int Orthop. 2012 Dec;36(12):2447-56. doi: 10.1007/s00264-012-1669-4. Epub 2012 Oct 7. PubMed 23052278 ↗
  • Guilbert S, Chassaing V, Radier C, Hulet C, Remy F, Chouteau J, Chotel F, Boisrenoult P, Sebilo A, Ferrua P, Ehkirch FP, Bertin D, Dejour D; French Arthroscopy Society (SFA). Axial MRI index of patellar engagement: a new method to assess patellar instability. Orthop Traumatol Surg Res. 2013 Dec;99(8 Suppl):S399-405. doi: 10.1016/j.otsr.2013.10.006. Epub 2013 Nov 20. PubMed 24268843 ↗

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03304119
Lead sponsor
Ramsay Générale de Santé
Collaborators
Dr Vincent Chassaing, European Clinical Trial Experts Network
Responsible party
Sponsor
First posted
Oct 6, 2017
Start date
Apr 1, 2016
Primary completion
Dec 30, 2016
Completion
Dec 30, 2016
Results posted
Mar 11, 2019
Last update
Mar 20, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion