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

Management Of The Partial Lesions Of The Fingers Flexor Tendons, Prospective Randomized Trial Of 2 Surgical Procedures: Tangential Resection Versus Direct Suture

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)

Study Overview

• Status: Terminated
• Conditions: Flexor Tendon Injury; Lesions Of The Fingers Flexor Tendons
• Intervention / Treatment: Procedure: tangential resection; Procedure: suture

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67000
    • CHU Strasbourg,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tangential resection; the tendon's injury is treated with a tangential resection	Procedure: 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
Active Comparator: Suture; The tendon's injury is sutured	Procedure: suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Sybille FACCA, MD, CHU Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: May 27, 2015
• First Submitted That Met QC Criteria: June 2, 2015
• First Posted (Estimate): June 3, 2015

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: partial section of the flexor tendons
• Additional Relevant MeSH Terms: Wounds and Injuries; Tendon Injuries
• Other Study ID Numbers: 6021