Evaluation of the Mobility of the Digital Flexor Tendons (DynamicMRI)

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

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

Study Overview

• Status: Completed
• Conditions: Tendon Injury - Hand; Tendon Rupture; Flexor Digitorum Longus on the Right; Flexor Digitorum Longus on the Left

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • CHRU de Brest
  • Brest, France, 29240
    • HIA
  • Brest, France, 29200
    • Clinique Keraudren

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patient with flexor tendon injury in zone 2 and insufficient functional after surgery with MRI requested for exploration

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flexor tendon excursion	Imaging of flexor tendon excursion in the hand after surgery during motion with MRI	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 31, 2019
• Primary Completion (ACTUAL): December 8, 2020
• Study Completion (ACTUAL): December 8, 2020

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (ACTUAL): January 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Tendon Injuries
• Other Study ID Numbers: 29BRC18.0214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending three years maximum following the last visit of the last patient
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No