Repair Of Flexor Tendon In Zone II Using Minimal Incisions

Not Applicable

Completed

• Conditions: Flexor Tendon Rupture
• Interventions: Procedure: repair of flexor tendon in Zone II

• Registration Number: NCT05809102
• Lead Sponsor: Assiut University

Brief Summary

Repair of the zone II flexor tendon of the hand using minimal incisions is successful with good results which will improve the outcome of the repair.

Detailed Description

Flexor tendon laceration in the hand is a common injury with unique characteristics owing to the anatomy of flexor tendons contained within a flexor sheath, requiring good surgical technique as well as strict rehabilitation protocol for regaining function.

The hand is divided into 5 zones (Verdan's). Zone II is described by Bunnel as "No Man's Land" historically back to the 14th century (an area outside London used for executions) because it was previously believed that primary repair should not be done in this zone. After understanding flexor tendon anatomy, biomechanics, and healing new techniques of surgery and anesthesia repair is possible with good results.

Lacerated tendons in zone II can retract proximally to the PIP if the vinculum longus is intact or into the palm if it is disrupted. It will not retract to the level of the wrist because of the origin of the lumbrical insertion into the extensor mechanism.

The laceration can be extended in a Brunner incision or a mid-lateral exposure but it is better skin incisions are minimal to minimize postoperative finger edema, potential adhesions, and injury of any delicate structures.

There are a lot of techniques to retrieve the proximal tendon end as milking, using a hemostat or second incision proximal to the A1 pulley where the tendon is tied to a looped wire of silastic tube and pulled distally through the laceration in the tendon sheath. But little studies discuss the effect of minimal incision on functional outcomes post-operative.

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-30
• Status Verified: 2023-03
• Study First Submitted: 2023-03-19
• Study First Submitted QC: 2023-03-30
• Last Update Submitted: 2023-03-30
• Study First Posted: 2023-04-12
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Age: between 16-60 years.

• Flexor tendon injuries of zone II of any medial four digits in both genders.
• within two weeks.
• Sharp mechanism of injury.
• Single-level injury
• Minimal surgical incision.

Exclusion Criteria

• Age less than sixteen years old or more than sixty years old.
• Amputation requiring replantation.
• Vascular injury requiring revascularization
• Associated fractures close to the tendon injury.
• Combined flexor and extensor tendon injury.
• Multiple-level injury
• Tendon substance loss
• Insufficient skin and soft tissue coverage.
• Surgical incision for whole tendon exposure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Minimal incisions	repair of flexor tendon in Zone II	Repair of Zone II using minimal incisions

Primary Outcome Measures

Name	Time	Method
range of motions	end point 6 months post-operative	range of motions of fingers using Jamar finger goniometer

Secondary Outcome Measures

Name	Time	Method
complications	end point 6 months post-operative	as adhesion formation, which limits active range of motion. joint contracture, tendon rupture, triggering, and pulley failure with tendon bowstringin Infection or neuroma
Healing vs failure of repair	baseline	questionnaire: can flex finger or not (yes or no)
DASH score using DASH questionnaire	6 months	Disabilites of the Arm , Shoulder , Hand score (0-100)

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt