Repair Of Flexor Tendon In Zone II Using Minimal Incisions

March 30, 2023 updated by: Mina S. Fekry, Assiut University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
range of motions
Time Frame: end point 6 months post-operative
range of motions of fingers using Jamar finger goniometer
end point 6 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications
Time Frame: 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
end point 6 months post-operative
Healing vs failure of repair
Time Frame: baseline
questionnaire: can flex finger or not (yes or no)
baseline
DASH score using DASH questionnaire
Time Frame: 6 months
Disabilites of the Arm , Shoulder , Hand score (0-100)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

March 19, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Minimal Incisions in Zone II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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