Repair Of Flexor Tendon In Zone II Using Minimal Incisions

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05809102
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 34.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Flexor Tendon Rupture	Procedure: repair of flexor tendon in Zone II	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Minimal incisions in repair of Zone II flexor tendon of the hand instead of whole exposure of the tendonMinimal incisions in repair of Zone II flexor tendon of the hand instead of whole exposure of the tendon
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Results Of Repair Of Flexor Tendon In Zone II Using Minimal Incisions, A Case Series Study
• Actual Study Start Date: Feb 1, 2020
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Minimal incisions Repair of Zone II using minimal incisions	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

Outcome Measures

Primary Outcome Measures

1. range of motions [end point 6 months post-operative]

   range of motions of fingers using Jamar finger goniometer

Secondary Outcome Measures

1. 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

2. Healing vs failure of repair [baseline]

   questionnaire: can flex finger or not (yes or no)

3. DASH score using DASH questionnaire [6 months]

   Disabilites of the Arm , Shoulder , Hand score (0-100)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University Hospital	Assiut		Egypt	71515

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Mina S. Fekry, assitant lecturer, Assiut University
• ClinicalTrials.gov Identifier: NCT05809102
• Other Study ID Numbers: Minimal Incisions in Zone II
• First Posted: Apr 12, 2023
• Last Update Posted: Apr 12, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rupture

Study Results

No Results Posted as of Apr 12, 2023