Clinical trial NCT03304119: Torsion of the Tibial Tuberosity, a New Factor of Patellar Instability?
Official title: Torsion of the Tibial Tuberosity, a New Factor of Patellar Instability?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patellar Instability
Patellar Dislocation
Keywords: Torsion of tibial tuberosity
Recurrent patellar dislocation
MRI Measurements
Patellar instability
Patellar dislocation
Tibial tubercle position
Tibial tubercle torsion
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: Dr Vincent Chassaing
name: European Clinical Trial Experts Network
First posted: 2017-10-06
Enrollment: 92
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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)

Primary outcomes:
measure: Existence of Tibial Tuberosity Torsion.
timeFrame: 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:
measure: Measure of Patellar Tilt
timeFrame: 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
measure: Distance TT-TG Tibial Tuberosity and Trochlear Groove
timeFrame: 4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.
Other outcomes:
Locations:
city: Paris
country: France
facility: ECTEN
state: IDF
Study officials:
References:
citation: 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.
citation: The Patellofemoral Joint - State of the Art in Evaluation and Management. ISAKOS 2014. Alberto Gobbi, Joao Espregueira-Mendes, Norima Nakamura Editors
citation: 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.
citation: Biedert RM. [Osteotomies]. Orthopade. 2008 Sep;37(9):872, 874-6, 878-80 passim. doi: 10.1007/s00132-008-1294-5. German.
citation: 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.
citation: 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.
citation: 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.