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Compare the Outcomes of Zone 2 Flexor Tendon Repair of the Hand Under General Anesthesia Versus WALANT

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04089124
Collaborator
(none)
100
Enrollment
2
Arms
31
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Comparison between results of General anesthesia and Walant in repair of cut flexor zone 2

Condition or Disease Intervention/Treatment Phase
  • Procedure: surgery of zone 2 cut flexor repair
 N/A

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 5 zones (Verdan's). Zone 2 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 2 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
repair zone 2 cut flexor of hand under GA and Walantrepair zone 2 cut flexor of hand under GA and Walant
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial to Compare the Outcomes of Zone 2 Flexor Tendon Repair of the Hand Under General Anesthesia Versus Wide Awake Local Anesthesia no Tourniquet
Anticipated Study Start Date :
Sep 15, 2019
Anticipated Primary Completion Date :
Dec 15, 2021
Anticipated Study Completion Date :
Apr 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: repair using General anesthesia ( control group)

Surgery repair zone 2 under GA

Procedure: surgery of zone 2 cut flexor repair
we will repair tendon of FDP. use 6 strand technique using PDS 4/0 core suture - vicryl 5/0 running suture
Other: repair using Walant

Surgery repair zone 2 under WALANT

Procedure: surgery of zone 2 cut flexor repair
we will repair tendon of FDP. use 6 strand technique using PDS 4/0 core suture - vicryl 5/0 running suture

Outcome Measures

Primary Outcome Measures

  1. Healing vs failure of repair [baseline]

    if can move and use flexor tendons again or not

Secondary Outcome Measures

  1. range of motions [baseline (Follow up after 2 weeks for assessment ( wound & stitches & physiotherapy) Then after 1.5 months , 3 months , 4.5 months and 6 months .)]

    The functions of treated fingers were calculated using original Strickland and Glogovac criteria: (active PIP + distal interphalangeal [DIP] flexion - extension lag at PIP and DIP)/175° X 100 equals the percentage of normal active PIP and DIP motion. Results were classified as excellent (85%-100% of normal IP motion), good (70%-84% of normal), fair(50%-69% of normal), or poor (_50% of normal).

  2. complications [baseline]

    as adhesion formation, which limits active range of motion. joint contracture, tendon rupture, triggering, and pulley failure with tendon bowstringin Infection or neuroma

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Acute zone II flexor tendon injuries of the hand in both genders.

  • Cooperative patients aged between 16-60 years.

Exclusion Criteria:

  • Uncooperative patients

  • Age less than sixteen years old or more than sixty years old .

  • Associated fractures close to the tendon injury.

  • Vascular injury requiring revascularization

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mina S. Fekry, resident, Assiut University
ClinicalTrials.gov Identifier:
NCT04089124
Other Study ID Numbers:
  • zone 2 flexor repair
First Posted:
Sep 13, 2019
Last Update Posted:
Sep 13, 2019
Last Verified:
Sep 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 13, 2019