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

NCT04089124 | Completed

• 1 other identifier: zone II flexor repair
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cut Flexor Hand; Walant; General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• complications

  baseline

• Healing vs failure of repair

  baseline

• DASH score using DASH questionnaire

  6 months

Study Arms (2)

repair using General anesthesia ( control group)

OTHER

Surgery repair zone II under GA

Procedure: surgery of zone II cut flexor repair

repair using Walant

OTHER

Surgery repair zone II under WALANT

Procedure: surgery of zone II cut flexor repair

Interventions

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

repair using General anesthesia ( control group); repair using Walant

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

Related Publications (14)

• Wolfe SW, Pederson WC, Hotchkiss RN, Kozin SH , Cohen MS. Green's Operative Hand Surgery E-book. Elsevier Health sciences ; 2016 Feb 24.

  BACKGROUND

• Canale ST, Beaty JH, Campbell WC. Campbell's operative orthopaedics. 2013.

  BACKGROUND

• Lalonde D. Wide Awake Hand Surgery . CRC press. 2016 Jan 27.

  BACKGROUND

• Griffin M, Hindocha S, Jordan D, Saleh M, Khan W. An overview of the management of flexor tendon injuries. Open Orthop J. 2012;6:28-35. doi: 10.2174/1874325001206010028. Epub 2012 Feb 23.

  PMID: 22431948 BACKGROUND

• Farnebo S, Chang J. Practical management of tendon disorders in the hand. Plast Reconstr Surg. 2013 Nov;132(5):841e-853e. doi: 10.1097/PRS.0b013e3182a48ccf.

  PMID: 24165636 BACKGROUND

• Steiner MM, Calandruccio JH. Use of Wide-awake Local Anesthesia No Tourniquet in Hand and Wrist Surgery. Orthop Clin North Am. 2018 Jan;49(1):63-68. doi: 10.1016/j.ocl.2017.08.008.

  PMID: 29145985 BACKGROUND

• Pires Neto PJ, Moreira LA, Las Casas PP. Is it safe to use local anesthesia with adrenaline in hand surgery? WALANT technique. Rev Bras Ortop. 2017 Jul 19;52(4):383-389. doi: 10.1016/j.rboe.2017.05.006. eCollection 2017 Jun-Jul.

  PMID: 28884094 BACKGROUND

• Lalonde DH, Kozin S. Tendon disorders of the hand. Plast Reconstr Surg. 2011 Jul;128(1):1e-14e. doi: 10.1097/PRS.0b013e3182174593.

  PMID: 21701291 BACKGROUND

• Lalonde DH. Latest Advances in Wide Awake Hand Surgery. Hand Clin. 2019 Feb;35(1):1-6. doi: 10.1016/j.hcl.2018.08.002.

  PMID: 30470325 BACKGROUND

• Higgins A, Lalonde DH, Bell M, McKee D, Lalonde JF. Avoiding flexor tendon repair rupture with intraoperative total active movement examination. Plast Reconstr Surg. 2010 Sep;126(3):941-945. doi: 10.1097/PRS.0b013e3181e60489.

  PMID: 20463621 BACKGROUND

• Festen-Schrier VJMM, Amadio PC. Wide Awake Surgery as an Opportunity to Enhance Clinical Research. Hand Clin. 2019 Feb;35(1):93-96. doi: 10.1016/j.hcl.2018.08.003.

  PMID: 30470336 BACKGROUND

• Osada D, Fujita S, Tamai K, Yamaguchi T, Iwamoto A, Saotome K. Flexor tendon repair in zone II with 6-strand techniques and early active mobilization. J Hand Surg Am. 2006 Jul-Aug;31(6):987-92. doi: 10.1016/j.jhsa.2006.03.012.

  PMID: 16843161 BACKGROUND

• Wong YR, Lee CS, Loke AM, Liu X, Suzana MJ I, Tay SC. Comparison of Flexor Tendon Repair Between 6-Strand Lim-Tsai With 4-Strand Cruciate and Becker Technique. J Hand Surg Am. 2015 Sep;40(9):1806-11. doi: 10.1016/j.jhsa.2015.05.007. Epub 2015 Jun 30.

  PMID: 26142080 BACKGROUND

• Kleinert HE, Spokevicius S, Papas NH. History of flexor tendon repair. J Hand Surg Am. 1995 May;20(3 Pt 2):S46-52. doi: 10.1016/s0363-5023(95)80169-3. No abstract available.

  PMID: 7642949 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator

Model Details: repair zone II cut flexor of hand under GA and Walant

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 13, 2019
• Study Start: February 1, 2020
• Primary Completion: December 15, 2021
• Study Completion: June 30, 2022
• Last Updated: November 30, 2022

Record last verified: 2021-11

Locations

EG (1)