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Repair Of Flexor Tendon In Zone II Using Minimal Incisions

Primary Purpose

Flexor Tendon Rupture

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
repair of flexor tendon in Zone II
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flexor Tendon Rupture

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age: between 16-60 years. Flexor tendon injuries of zone II of any medial four digits in both genders. within two weeks. Sharp mechanism of injury. Single-level injury Minimal surgical incision. Exclusion Criteria: Age less than sixteen years old or more than sixty years old. Amputation requiring replantation. Vascular injury requiring revascularization Associated fractures close to the tendon injury. Combined flexor and extensor tendon injury. Multiple-level injury Tendon substance loss Insufficient skin and soft tissue coverage. Surgical incision for whole tendon exposure.

Sites / Locations

  • Assiut University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Minimal incisions

Arm Description

Repair of Zone II using minimal incisions

Outcomes

Primary Outcome Measures

range of motions
range of motions of fingers using Jamar finger goniometer

Secondary Outcome Measures

complications
as 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 repair
questionnaire: can flex finger or not (yes or no)
DASH score using DASH questionnaire
Disabilites of the Arm , Shoulder , Hand score (0-100)

Full Information

First Posted
March 19, 2023
Last Updated
March 30, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05809102
Brief Title
Repair Of Flexor Tendon In Zone II Using Minimal Incisions
Official Title
Results Of Repair Of Flexor Tendon In Zone II Using Minimal Incisions, A Case Series Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Repair of the zone II flexor tendon of the hand using minimal incisions is successful with good results which will improve the outcome of the repair.
Detailed Description
Flexor tendon laceration in the hand is a common injury with unique characteristics owing to the anatomy of flexor tendons contained within a flexor sheath, requiring good surgical technique as well as strict rehabilitation protocol for regaining function. The hand is divided into 5 zones (Verdan's). Zone II is described by Bunnel as "No Man's Land" historically back to the 14th century (an area outside London used for executions) because it was previously believed that primary repair should not be done in this zone. After understanding flexor tendon anatomy, biomechanics, and healing new techniques of surgery and anesthesia repair is possible with good results. Lacerated tendons in zone II can retract proximally to the PIP if the vinculum longus is intact or into the palm if it is disrupted. It will not retract to the level of the wrist because of the origin of the lumbrical insertion into the extensor mechanism. The laceration can be extended in a Brunner incision or a mid-lateral exposure but it is better skin incisions are minimal to minimize postoperative finger edema, potential adhesions, and injury of any delicate structures. There are a lot of techniques to retrieve the proximal tendon end as milking, using a hemostat or second incision proximal to the A1 pulley where the tendon is tied to a looped wire of silastic tube and pulled distally through the laceration in the tendon sheath. But little studies discuss the effect of minimal incision on functional outcomes post-operative.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flexor Tendon Rupture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Minimal incisions in repair of Zone II flexor tendon of the hand instead of whole exposure of the tendon
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minimal incisions
Arm Type
Other
Arm Description
Repair of Zone II using minimal incisions
Intervention Type
Procedure
Intervention Name(s)
repair of flexor tendon in Zone II
Intervention Description
Repair of Zone II flexor tendon of the hand using minimal incisions instead of whole tendon exposure
Primary Outcome Measure Information:
Title
range of motions
Description
range of motions of fingers using Jamar finger goniometer
Time Frame
end point 6 months post-operative
Secondary Outcome Measure Information:
Title
complications
Description
as adhesion formation, which limits active range of motion. joint contracture, tendon rupture, triggering, and pulley failure with tendon bowstringin Infection or neuroma
Time Frame
end point 6 months post-operative
Title
Healing vs failure of repair
Description
questionnaire: can flex finger or not (yes or no)
Time Frame
baseline
Title
DASH score using DASH questionnaire
Description
Disabilites of the Arm , Shoulder , Hand score (0-100)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: between 16-60 years. Flexor tendon injuries of zone II of any medial four digits in both genders. within two weeks. Sharp mechanism of injury. Single-level injury Minimal surgical incision. Exclusion Criteria: Age less than sixteen years old or more than sixty years old. Amputation requiring replantation. Vascular injury requiring revascularization Associated fractures close to the tendon injury. Combined flexor and extensor tendon injury. Multiple-level injury Tendon substance loss Insufficient skin and soft tissue coverage. Surgical incision for whole tendon exposure.
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
ZIP/Postal Code
71515
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
22431948
Citation
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.
Results Reference
background
PubMed Identifier
23325961
Citation
Kotwal PP, Ansari MT. Zone 2 flexor tendon injuries: Venturing into the no man's land. Indian J Orthop. 2012 Nov;46(6):608-15. doi: 10.4103/0019-5413.104183.
Results Reference
background
PubMed Identifier
22720265
Citation
Schoffl V, Heid A, Kupper T. Tendon injuries of the hand. World J Orthop. 2012 Jun 18;3(6):62-9. doi: 10.5312/wjo.v3.i6.62.
Results Reference
background

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Repair Of Flexor Tendon In Zone II Using Minimal Incisions

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