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Treatment for Partial Lesions of the Fingers Flexor Tendons : Tangential Resection or Direct Suture (FLEXOR)

Primary Purpose

Flexor Tendon Injury, Lesions Of The Fingers Flexor Tendons

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tangential resection
suture
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flexor Tendon Injury focused on measuring partial section of the flexor tendons

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • wound dating less than 48 hours
  • partial section from 50 % to 75 % of the flexor tendons (deep and/or superficial flexors, long flexor of the thumb) in zones 1, 2, 3, T1 and T2
  • tendinous injuries on a single finger

Exclusion Criteria:

-

Sites / Locations

  • CHU Strasbourg,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tangential resection

Suture

Arm Description

the tendon's injury is treated with a tangential resection

The tendon's injury is sutured

Outcomes

Primary Outcome Measures

Total active motion Grasp
Total active motion is the addition of angles in flexion of IPP, IPD and MCP joints of a finger in active mobility

Secondary Outcome Measures

Full Information

First Posted
May 27, 2015
Last Updated
August 19, 2019
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02461680
Brief Title
Treatment for Partial Lesions of the Fingers Flexor Tendons : Tangential Resection or Direct Suture
Acronym
FLEXOR
Official Title
Management Of The Partial Lesions Of The Fingers Flexor Tendons, Prospective Randomized Trial Of 2 Surgical Procedures: Tangential Resection Versus Direct Suture
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulty
Study Start Date
February 2016 (Actual)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Flexors tendon injuries are frequent and serious with a potential of definitive functional aftereffects. In the case of partial injury, the treatment is debated. There are 2 techniques of possible repair, the direct suture and the tangential resection. The investigators have already demonstrated that this last technique was favorable for injuries going to 50 %. In the case of partial section between 50 and 75 %, the investigators think that the technique of tangential resection compared with the direct suture would not increase the risks of secondary breaks, would authorize even an immediate mobilization and would decrease the secondary complications. The main objective is to highlight that the tangential resection is not lower than the classic technique on the clinical plan The secondary objectives are to highlight the non-inferiority of the tangential technique in clinical terms (pains, dexterity, complications), radiologics (MRI, ultrasound) and functional (function, go back to leisures and professional activities)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flexor Tendon Injury, Lesions Of The Fingers Flexor Tendons
Keywords
partial section of the flexor tendons

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tangential resection
Arm Type
Experimental
Arm Description
the tendon's injury is treated with a tangential resection
Arm Title
Suture
Arm Type
Active Comparator
Arm Description
The tendon's injury is sutured
Intervention Type
Procedure
Intervention Name(s)
tangential resection
Intervention Description
the tendon's injury is treated with a tangential resection performed with a surgical blade N°11 The shape of the tangential resection was adapted such that the cross-section disappered
Intervention Type
Procedure
Intervention Name(s)
suture
Primary Outcome Measure Information:
Title
Total active motion Grasp
Description
Total active motion is the addition of angles in flexion of IPP, IPD and MCP joints of a finger in active mobility
Time Frame
third month,

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: wound dating less than 48 hours partial section from 50 % to 75 % of the flexor tendons (deep and/or superficial flexors, long flexor of the thumb) in zones 1, 2, 3, T1 and T2 tendinous injuries on a single finger Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sybille FACCA, MD
Organizational Affiliation
CHU Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Strasbourg,
City
Strasbourg
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Treatment for Partial Lesions of the Fingers Flexor Tendons : Tangential Resection or Direct Suture

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