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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04089124
Enrollment
86
Registered
2019-09-13
Start date
2020-02-01
Completion date
2022-06-30
Last updated
2022-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cut Flexor Hand, General Anesthesia, Walant

Brief summary

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

Detailed description

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

Interventions

PROCEDUREsurgery of zone II cut flexor repair

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

repair zone II cut flexor of hand under GA and Walant

Eligibility

Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
range of motions using Jamar finger goniometerbaseline (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

MeasureTime frameDescription
complicationsbaselineas adhesion formation, which limits active range of motion. joint contracture, tendon rupture, triggering, and pulley failure with tendon bowstringin Infection or neuroma
Healing vs failure of repairbaselineif can move and use flexor tendons again or not
DASH score using DASH questionnaire6 monthsDisabilites of the Arm , Shoulder , Hand

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026