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

Study Overview
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Brief Summary
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Comparison between results of repair of cut flexor zone II under General anesthesia and Walant

Detailed Description
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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

Official Title
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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

Conditions
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Cut Flexor Hand, Walant, General Anesthesia

Intervention / Treatment
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* Procedure: surgery of zone II cut flexor repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: repair zone II cut flexor of hand under GA and Walant
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: repair using General anesthesia ( control group)<br>Surgery repair zone II under GA | Procedure: surgery of zone II cut flexor repair<br>* we will repair tendon of FDP only using 6 strand technique using PDS 4/0 core suture - prolene 6/0 running suture<br>|
| Other: repair using Walant<br>Surgery repair zone II under WALANT | Procedure: surgery of zone II cut flexor repair<br>* we will repair tendon of FDP only using 6 strand technique using PDS 4/0 core suture - prolene 6/0 running suture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| range of motions using Jamar finger goniometer | The functions of treated fingers were calculated using original Strickland and Glogovac criteria | baseline (2 weeks, 1.5 months , 3 months , 4.5 months and 6 months .) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications | as adhesion formation, which limits active range of motion. joint contracture, tendon rupture, triggering, and pulley failure with tendon bowstringin Infection or neuroma | baseline | 
| Healing vs failure of repair | if can move and use flexor tendons again or not | baseline | 
| DASH score using DASH questionnaire | Disabilites of the Arm , Shoulder , Hand | 6 months |