Trial Outcomes & Findings for Torsion of the Tibial Tuberosity, a New Factor of Patellar Instability? (NCT NCT03304119)

NCT ID: NCT03304119

Last Updated: 2019-03-20

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 92 participants
• Primary outcome timeframe: 4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.
• Results posted on: 2019-03-20

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	37	55
Overall Study COMPLETED	37	55
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Patellar Instability Group n=37 Participants Group of patients with patellar instability stemming from a recurrent patellar dislocation	Control Group Control n=55 Participants Group that has not been checked for patellar instability.	Total n=92 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=37 Participants	1 Participants n=55 Participants	2 Participants n=92 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=37 Participants	53 Participants n=55 Participants	89 Participants n=92 Participants
Age, Categorical >=65 years	0 Participants n=37 Participants	1 Participants n=55 Participants	1 Participants n=92 Participants
Age, Continuous mean	28.6 years STANDARD_DEVIATION 10.7 • n=37 Participants	46 years STANDARD_DEVIATION 14 • n=55 Participants	39 years STANDARD_DEVIATION 15.4 • n=92 Participants
Sex: Female, Male Female	23 Participants n=37 Participants	19 Participants n=55 Participants	42 Participants n=92 Participants
Sex: Female, Male Male	14 Participants n=37 Participants	36 Participants n=55 Participants	50 Participants n=92 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	37 participants n=37 Participants	55 participants n=55 Participants	92 participants n=92 Participants

PRIMARY outcome

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

Population: Analysis based on the IRM available

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

Outcome measures

Measure	Patellar Instability Group n=37 Participants Group of patients with patellar instability stemming from a recurrent patellar dislocation	Control Group Control n=55 Participants Group that has not been checked for patellar instability.
Existence of Tibial Tuberosity Torsion.	17.5 degre Interval 13.0 to 23.9	5.3 degre Interval 3.4 to 8.4

SECONDARY outcome

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

Population: Patients with IRM available.

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

Outcome measures

Measure	Patellar Instability Group n=37 Participants Group of patients with patellar instability stemming from a recurrent patellar dislocation	Control Group Control n=55 Participants Group that has not been checked for patellar instability.
Measure of Patellar Tilt	19.8 degre Interval 13.8 to 27.6	5.3 degre Interval 2.5 to 8.2

SECONDARY outcome

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

distance between Tibial Tuberosity and Trochlear Groove

Outcome measures

Measure	Patellar Instability Group n=37 Participants Group of patients with patellar instability stemming from a recurrent patellar dislocation	Control Group Control n=55 Participants Group that has not been checked for patellar instability.
Distance TT-TG Tibial Tuberosity and Trochlear Groove	17 milimeters Interval 12.2 to 20.1	8.4 milimeters Interval 6.7 to 9.8

Adverse Events

Patellar Instability Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

V Chassaing

Hôpital Privé Antony

Phone: +33 1 46 74 37 00

Email: vchassaing92@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place