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

Patellar Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304119
• Other study ID #: RGDS TTA study
• Status: Completed
• Start date: April 1, 2016
• Est. completion date: December 30, 2016

Study information

• Verified date: February 2018
• Source: Ramsay Générale de Santé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 30, 2016
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Patellar Dislocation
• Patellar Instability

Locations

Country	Name	City	State
France	ECTEN	Paris	IDF

Sponsors (3)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	Dr Vincent Chassaing, European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

References & Publications (7)

Biedert RM. [Osteotomies]. Orthopade. 2008 Sep;37(9):872, 874-6, 878-80 passim. doi: 10.1007/s00132-008-1294-5. Review. German. — View 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. Erratum in: Radiographics. 2011 Mar-Apr;31(2):624. — View Citation

Guilbert S, Chassaing V, Radier C, Hulet C, Rémy 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. — View 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. — View 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. Review. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.
Secondary	Measure of Patellar Tilt	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
Secondary	Distance TT-TG Tibial Tuberosity and Trochlear Groove	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.