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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03823755
Other study ID # 29BRC18.0214
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 31, 2019
Est. completion date December 8, 2020

Study information

Verified date February 2023
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To study flexor tendon excursion in the hand after surgery by dynamic MRI


Description:

The study of the movement of the digital flexor tendon operated on MRI could lead to a better understanding of the biomechanics of this tendon after surgery, to objectively assess the repair of the tendon and the recovery of its mobility. The visualization of the aspect and the movement of this operated tendon would make it possible to adapt the rehabilitation for each patient and to prevent the occurrence of complications which limit functional recovery and source of handicap. The analysis of the imaging in patients evolving would establish useful criteria the surgeon to judge the evolution of the operated tendon. The first step consists in evaluating the feasibility of the acquisition of dynamic sequences in MRI and the possibility of observing the movement of the flexor tendon operated during the mobilization of the finger, and comparing the biomechanical data obtained with those of the nonoperated tendons and experimental models.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 8, 2020
Est. primary completion date December 8, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - flexor tendon injury in zone 2 - treatment by surgery - insufficient functional outcome after surgery - MRI requested by surgeon Exclusion Criteria: - pregnancy - MRI contraindications - previous surgery on the hand - rheumatic disorder

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU de Brest Brest
France Clinique Keraudren Brest
France HIA Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Flexor tendon excursion Imaging of flexor tendon excursion in the hand after surgery during motion with MRI 1 year
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