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Completed

NCT Number: NCT04089124

Compare the Outcomes of Zone II Flexor Tendon Repair of the Hand Under General Anesthesia Versus WALANT

Comparison between results of repair of cut flexor zone II under General anesthesia and Walant

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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

Cut Flexor is common injury ,has unique characters as they cannot heal without surgical treatment, unique anatomy of the tendons running through flexor tendon sheaths to function and postoperative management &mobilization to prevent adhesions and improve gliding but risk of rupture.

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

General anesthesia has been the standard technique for along time. wide awake local anesthesia no tourniquet. (WALANT),using safe drugs lidocaine for anesthesia and epinephrine for hemostasis, the investigators can do operations while patient is awake.

WALANT has been recommended by some surgeons to be the next standard for repair of zone 2 injuries .

This techniques has a lot of Advantages in repair zone II as 1) intraoperative testing of the flexor repair by active movement to exclude any gap. and lets the surgeon see that the repair fits through the pulleys with active movement.

2)sheath and pulley damage are minimized, as flexor tendons are repaired through small transverse sheathotomy incisions 3) the surgeon can interview the patient during the procedure and assess the ability to comply with the postoperative regimen 4) the risks of general anesthesia are avoided in most patients. Negative effects of general anesthesia include nausea and vomiting, hospital admission for anesthesia recovery, exacerbation of comorbidity issues such as diabetes, aggressive flexion by the patient emerging from general anesthesia,and others

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Acute zone II flexor tendon injuries of the hand in both genders in medial four fingers.
  • Cooperative patients aged between 16-60 years.
  • Sharp mechanism of injury
  • Single level injury

Exclusion criteria

  • Age less than sixteen years old or more than sixty years old .
  • Associated fractures close to the tendon injury.
  • Vascular injury requiring revascularization
  • Multiple level injury
  • Combined flexor and extensor laceration
  • Insufficient skin and soft tissue coverage
  • Tendon substance loss

Treatment and study plan

surgery of zone II cut flexor repair

Procedure

we will repair tendon of FDP only using 6 strand technique using PDS 4/0 core suture - prolene 6/0 running suture

Primary outcomes

  1. range of motions using Jamar finger goniometer

    Time frame: baseline (2 weeks, 1.5 months , 3 months , 4.5 months and 6 months .)

    The functions of treated fingers were calculated using original Strickland and Glogovac criteria

Secondary outcomes

  1. complications

    Time frame: baseline

    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

    if can move and use flexor tendons again or not

  3. DASH score using DASH questionnaire

    Time frame: 6 months

    Disabilites of the Arm , Shoulder , Hand

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Randomized Controlled Trial to Compare the Outcomes Of Zone II Flexor Tendon Repair of the Hand Under General Anesthesia Versus Wide Awake Local Anesthesia No Tourniquet

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 13, 2019
Registry last updated
Nov 30, 2022

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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