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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Patellar Instability
Patellar Dislocation
Enrollment 92
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patellar Instability Group Control Group Control
Hide Arm/Group Description Group of patients with patellar instability stemming from a recurrent patellar dislocation Group that has not been checked for patellar instability.
Period Title: Overall Study
Started 37 55
Completed 37 55
Not Completed 0 0
Arm/Group Title Patellar Instability Group Control Group Control Total
Hide Arm/Group Description Group of patients with patellar instability stemming from a recurrent patellar dislocation Group that has not been checked for patellar instability. Total of all reporting groups
Overall Number of Baseline Participants 37 55 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 55 participants 92 participants
<=18 years
1
   2.7%
1
   1.8%
2
   2.2%
Between 18 and 65 years
36
  97.3%
53
  96.4%
89
  96.7%
>=65 years
0
   0.0%
1
   1.8%
1
   1.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
mean Number Analyzed 37 participants 55 participants 92 participants
28.6  (10.7) 46  (14) 39  (15.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 55 participants 92 participants
Female
23
  62.2%
19
  34.5%
42
  45.7%
Male
14
  37.8%
36
  65.5%
50
  54.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 37 participants 55 participants 92 participants
37 55 92
1.Primary Outcome
Title Existence of Tibial Tuberosity Torsion.
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on the IRM available
Arm/Group Title Patellar Instability Group Control Group Control
Hide Arm/Group Description:
Group of patients with patellar instability stemming from a recurrent patellar dislocation
Group that has not been checked for patellar instability.
Overall Number of Participants Analyzed 37 55
Median (Inter-Quartile Range)
Unit of Measure: degre
17.5
(13.0 to 23.9)
5.3
(3.4 to 8.4)
2.Secondary Outcome
Title Measure of Patellar Tilt
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with IRM available.
Arm/Group Title Patellar Instability Group Control Group Control
Hide Arm/Group Description:
Group of patients with patellar instability stemming from a recurrent patellar dislocation
Group that has not been checked for patellar instability.
Overall Number of Participants Analyzed 37 55
Median (Inter-Quartile Range)
Unit of Measure: degre
19.8
(13.8 to 27.6)
5.3
(2.5 to 8.2)
3.Secondary Outcome
Title Distance TT-TG Tibial Tuberosity and Trochlear Groove
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patellar Instability Group Control Group Control
Hide Arm/Group Description:
Group of patients with patellar instability stemming from a recurrent patellar dislocation
Group that has not been checked for patellar instability.
Overall Number of Participants Analyzed 37 55
Median (Inter-Quartile Range)
Unit of Measure: milimeters
17
(12.2 to 20.1)
8.4
(6.7 to 9.8)
Time Frame Not Applicable. Study consist in IRM reading. NO adverse events has been collected. Not applicable, retrospective study based on available IRM
Adverse Event Reporting Description Not Applicable. Study consist in IRM reading. NO adverse events has been collected. Not applicable, retrospective study based on available IRM
 
Arm/Group Title Patellar Instability Group Control Group Control
Hide Arm/Group Description Group of patients with patellar instability stemming from a recurrent patellar dislocation Group that has not been checked for patellar instability.
All-Cause Mortality
Patellar Instability Group Control Group Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Patellar Instability Group Control Group Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patellar Instability Group Control Group Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: V Chassaing
Organization: Hôpital Privé Antony
Phone: +33 1 46 74 37 00
Publications:
The Patellofemoral Joint - State of the Art in Evaluation and Management. ISAKOS 2014. Alberto Gobbi, Joao Espregueira-Mendes, Norima Nakamura Editors
Responsible Party: Ramsay Générale de Santé
ClinicalTrials.gov Identifier: NCT03304119     History of Changes
Other Study ID Numbers: RGDS TTA study
First Submitted: September 26, 2017
First Posted: October 6, 2017
Results First Submitted: February 26, 2018
Results First Posted: March 11, 2019
Last Update Posted: March 20, 2019