NCT03823755

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

May 31, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2020

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

January 29, 2019

Last Update Submit

February 9, 2023

Conditions

Flexor Digitorum Longus on the RightFlexor Digitorum Longus on the LeftTendon RuptureTendon Injury - Hand

Outcome Measures

Primary Outcomes (1)

  • Flexor tendon excursion

    Imaging of flexor tendon excursion in the hand after surgery during motion with MRI

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • flexor tendon injury in zone 2
  • treatment by surgery
  • insufficient functional outcome after surgery
  • MRI requested by surgeon

You may not qualify if:

  • pregnancy
  • MRI contraindications
  • previous surgery on the hand
  • rheumatic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHRU de Brest

Brest, 29200, France

Location

Clinique Keraudren

Brest, 29200, France

Location

HIA

Brest, 29240, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2019

First Posted

January 30, 2019

Study Start

May 31, 2019

Primary Completion

December 8, 2020

Study Completion

December 8, 2020

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available after the publication of result and ending three years maximum following the last visit of the last patient
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

Locations

FR(3)