Evaluation of the Mobility of the Digital Flexor Tendons

Tendon Injury - Hand Clinical Trial

— DynamicMRI  

Official title:

Evaluation of the Mobility of the Digital Flexor Tendons Operated by Dynamic MRI: a Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823755
• Other study ID #: 29BRC18.0214
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Flexor Digitorum Longus on the Left
• Flexor Digitorum Longus on the Right
• Rupture
• Tendon Injuries
• Tendon Injury - Hand
• Tendon Rupture

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