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

NCT02461680 | Terminated

• 1 other identifier: 6021
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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)

Conditions

Flexor Tendon Injury; Lesions Of The Fingers Flexor Tendons

Keywords

partial section of the flexor tendons

Outcome Measures

Primary Outcomes (1)

• 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

  third month,

Study Arms (2)

Tangential resection

EXPERIMENTAL

the tendon's injury is treated with a tangential resection

Procedure: tangential resection

Suture

ACTIVE COMPARATOR

The tendon's injury is sutured

Procedure: suture

Interventions

tangential resection 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

Tangential resection

suture PROCEDURE

Suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

CHU Strasbourg,

Strasbourg, 67000, France

Location

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Sybille FACCA, MD

  CHU Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 3, 2015
• Study Start: February 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

FR (1)