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Completed

NCT Number: NCT05809102

Repair Of Flexor Tendon In Zone II Using Minimal Incisions

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.

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Key information

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospital

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

repair of flexor tendon in Zone II

Procedure

Repair of Zone II flexor tendon of the hand using minimal incisions instead of whole tendon exposure

Primary outcomes

  1. range of motions

    Time frame: end point 6 months post-operative

    range of motions of fingers using Jamar finger goniometer

Secondary outcomes

  1. 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

  2. Healing vs failure of repair

    Time frame: baseline

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

  3. DASH score using DASH questionnaire

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 12, 2023
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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