Repair Of Flexor Tendon In Zone II Using Minimal Incisions

Flexor Tendon Rupture Clinical Trial

Official title:

Results Of Repair Of Flexor Tendon In Zone II Using Minimal Incisions, A Case Series Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05809102
• Other study ID #: Minimal Incisions in Zone II
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Flexor Tendon Rupture
• Rupture

Intervention

Procedure:
• repair of flexor tendon in Zone II
Repair of Zone II flexor tendon of the hand using minimal incisions instead of whole tendon exposure

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Griffin M, Hindocha S, Jordan D, Saleh M, Khan W. An overview of the management of flexor tendon injuries. Open Orthop J. 2012;6:28-35. doi: 10.2174/1874325001206010028. Epub 2012 Feb 23. — View Citation

Kotwal PP, Ansari MT. Zone 2 flexor tendon injuries: Venturing into the no man's land. Indian J Orthop. 2012 Nov;46(6):608-15. doi: 10.4103/0019-5413.104183. — View Citation

Schoffl V, Heid A, Kupper T. Tendon injuries of the hand. World J Orthop. 2012 Jun 18;3(6):62-9. doi: 10.5312/wjo.v3.i6.62. — View Citation

Outcome

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