NCT03304119

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 11, 2019

Completed
Last Updated

March 20, 2019

Status Verified

February 1, 2018

Enrollment Period

9 months

First QC Date

September 26, 2017

Results QC Date

February 26, 2018

Last Update Submit

March 11, 2019

Conditions

Keywords

Torsion of tibial tuberosityRecurrent patellar dislocationMRI MeasurementsPatellar instabilityPatellar dislocationTibial tubercle positionTibial tubercle torsion

Outcome Measures

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

    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 (2)

  • Measure of Patellar Tilt

    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

    4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.

Study Arms (2)

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ECTEN

Paris, IDF, 75010, France

Location

Related Publications (7)

  • 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.

    PMID: 25632054BACKGROUND
  • The Patellofemoral Joint - State of the Art in Evaluation and Management. ISAKOS 2014. Alberto Gobbi, Joao Espregueira-Mendes, Norima Nakamura Editors

    BACKGROUND
  • 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.

    PMID: 20631363BACKGROUND
  • Biedert RM. [Osteotomies]. Orthopade. 2008 Sep;37(9):872, 874-6, 878-80 passim. doi: 10.1007/s00132-008-1294-5. German.

    PMID: 18682913BACKGROUND
  • 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.

    PMID: 4081137BACKGROUND
  • 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.

    PMID: 23052278BACKGROUND
  • 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.

    PMID: 24268843BACKGROUND

MeSH Terms

Conditions

Patellar Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesKnee InjuriesLeg Injuries

Results Point of Contact

Title
V Chassaing
Organization
Hôpital Privé Antony

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2017

First Posted

October 6, 2017

Study Start

April 1, 2016

Primary Completion

December 30, 2016

Study Completion

December 30, 2016

Last Updated

March 20, 2019

Results First Posted

March 11, 2019

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations