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

NCT ID: NCT02461680

Last Updated: 2019-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-02-28

Brief Summary

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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)

Detailed Description

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Conditions

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Flexor Tendon Injury Lesions Of The Fingers Flexor Tendons

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Tangential resection

the tendon's injury is treated with a tangential resection

Group Type EXPERIMENTAL

tangential resection

Intervention Type PROCEDURE

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

Suture

The tendon's injury is sutured

Group Type ACTIVE_COMPARATOR

suture

Intervention Type PROCEDURE

Interventions

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tangential resection

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

suture

Intervention Type PROCEDURE

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sybille FACCA, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Strasbourg

Locations

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CHU Strasbourg,

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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6021

Identifier Type: -

Identifier Source: org_study_id

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