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

Flexor Tendon Injury Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02461680
• Other study ID #: 6021
• Status: Terminated
• Phase: N/A
• Start date: February 2016
• Est. completion date: February 2019

Study information

• Verified date: August 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Flexor Tendon Injury
• Lesions Of The Fingers Flexor Tendons
• Tendon Injuries

Intervention

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
• suture

Locations

Country	Name	City	State
France	CHU Strasbourg,	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,