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Repair of Flexor Tendon Injuries With Eight Strand Core Stitch Without Postoperative Splinting

Primary Purpose

Flexor Tendon Repair

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Absorbable polydioxanone suture (PDS)
Sponsored by
Mina Micheal Anwer Fahmy
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flexor Tendon Repair

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Adult patient ( > 16 years)
  2. Flexor tendon injuries zones (II,III,IV,V)

Exclusion Criteria:

  1. Patients < 16 years
  2. Flexor tendon injuries zone I

2- Fracture of hand,wrist or forearm bones 3- Associated nerve injuries

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Early postoperative mobilisation of fingers (active & passive) - Follow up will be done according to DASH (Disability of arm,shoulder and hand) score at 6 weeks

    Secondary Outcome Measures

    Full Information

    First Posted
    May 3, 2019
    Last Updated
    May 3, 2019
    Sponsor
    Mina Micheal Anwer Fahmy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03938935
    Brief Title
    Repair of Flexor Tendon Injuries With Eight Strand Core Stitch Without Postoperative Splinting
    Official Title
    Repair of Flexor Tendon Injuries With Eight Strand Core Stitch Without Postoperative Splinting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2019 (Anticipated)
    Primary Completion Date
    February 2021 (Anticipated)
    Study Completion Date
    August 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mina Micheal Anwer Fahmy

    4. Oversight

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

    5. Study Description

    Brief Summary
    Evaluation of early active postoperative mobilisation in flexor tendon injuries without postoperative splinting
    Detailed Description
    Flexor tendon injuries are a common event as the tendons lie close to the skin and so are usually the result of either lacerations such as those from knives or glass, from crush injuries and occasionally they can rupture from where they are joined at the bone during contact sports such as football, rugby and wrestling. Flexor tendon injuries are a challenging problem for orthopaedic surgeons due to three main reasons. Firstly, flexor tendon injuries of the hands are a clinical problem because they cannot heal without surgical treatment, as the two ends need to be surgically brought together for the healing to occur unlike other tendons including the Achilles tendon where it could be placed into plantar flexion to heal. Secondly postoperative management needs to be carefully planned as mobilisation has shown to be essential to prevent adhesions and improve gliding but this can risk rupture. Lastly due to the unique anatomy of the tendons running through flexor tendon sheaths to function, surgeons need to plan preventing increasing the bulkiness of the tendon through its sheath, which is not always possible from scarring as this affects the functional outcome of the tendon -_ The ultimate goal of surgical intervention has remained constant: to achieve enough strength to allow early motion, to prevent adhesions within the tendon sheath, and to restore the finger to normal range of motion and function. The successful repair requires minimal gapping at the repair site or interference with tendon vascularity, secure suture knots, smooth junction of tendon end and having sufficient strength for healing. The strength of the core suture is one of the important factors for valid flexor tendon repair. It is obvious that an increased strand number increases repair gap resistance and strength

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    1 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Absorbable polydioxanone suture (PDS)
    Intervention Description
    PDS is a Polydioxanone synthetic monofilament which is absorbable.
    Primary Outcome Measure Information:
    Title
    Early postoperative mobilisation of fingers (active & passive) - Follow up will be done according to DASH (Disability of arm,shoulder and hand) score at 6 weeks
    Time Frame
    one and half month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adult patient ( > 16 years) Flexor tendon injuries zones (II,III,IV,V) Exclusion Criteria: Patients < 16 years Flexor tendon injuries zone I 2- Fracture of hand,wrist or forearm bones 3- Associated nerve injuries
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mina Micheal Anwer, MBBCh
    Phone
    01023428667
    Email
    minamicheeal@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yasser Mohamed Farouk, MD
    Phone
    01015808000
    Email
    yasserragheb@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26614935
    Citation
    Myer C, Fowler JR. Flexor Tendon Repair: Healing, Biomechanics, and Suture Configurations. Orthop Clin North Am. 2016 Jan;47(1):219-26. doi: 10.1016/j.ocl.2015.08.019.
    Results Reference
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    Repair of Flexor Tendon Injuries With Eight Strand Core Stitch Without Postoperative Splinting

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