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Subtalar Arthrodesis by Single Versus Double Screws

Primary Purpose

Subtalar Osteoarthritis Secondary to Inflammatory Arthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Subtalar Arthrodesis by Screws
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subtalar Osteoarthritis Secondary to Inflammatory Arthritis focused on measuring subtalar arthrodesis, screws

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients who will be operated by subtalar fusion for any indication Age range 18 - 65 Exclusion Criteria: Age < 18 years , > 65 Acute calceneal fracture Infection Non union Bone defect that need bone graft Refusing to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    A

    B

    Arm Description

    subtalar arthrodesis by single screw

    subtalar arthrodesis by double screws

    Outcomes

    Primary Outcome Measures

    Fusion rate
    subtalar fusion radiologically and clinically

    Secondary Outcome Measures

    Functional assessment -rate of complications(e.g. non-union, post-operative infections, Instability) -secondary surgery procedures
    by AOFAS Ankle-Hindfoot Scale

    Full Information

    First Posted
    March 21, 2023
    Last Updated
    March 21, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05795543
    Brief Title
    Subtalar Arthrodesis by Single Versus Double Screws
    Official Title
    Single Versus Double Screws Fixation of Subtalar Arthrodesis : A Prospective Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    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

    5. Study Description

    Brief Summary
    Compare clinical and radiological outcome of use of single screw versus double screws fixation for subtalar arthrodesis
    Detailed Description
    The subtalar joint consists of an anterior, posterior and medial joint facet, which allows for inversion - and eversion of the foot. Several pathologies may lead to pain originating from the subtalar joint, including primary arthritis, posttraumatic arthritis, congenital or acquired deformities, instability, tarsal coalition or inflammatory diseases Management of these pathologies variable including conservative and operative treatment once conservative treatment has failed subtalar fusion is a common surgical procedure which is a well-established and widely accepted There are many surgical techniques described for fusion , one of these techniques is fixation with screws The rate of non-union varies among authors between 0-46%, that's may due to lack of standardization of techniques should be used

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Subtalar Osteoarthritis Secondary to Inflammatory Arthritis
    Keywords
    subtalar arthrodesis, screws

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    participant divide to 2 groups first group subtalar arthrodesis by single screw second group subtalar arthrodesis by double screws
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Active Comparator
    Arm Description
    subtalar arthrodesis by single screw
    Arm Title
    B
    Arm Type
    Active Comparator
    Arm Description
    subtalar arthrodesis by double screws
    Intervention Type
    Procedure
    Intervention Name(s)
    Subtalar Arthrodesis by Screws
    Intervention Description
    Instruments: cannulated screws Steps: supine position , tournique over the thigh, using a extended lateral approach or sinus tarsi approach with joint debridement and preparation. Single-screw fixation was most often placed from posterior to anterior and double screws fixation was placed triangular pattern
    Primary Outcome Measure Information:
    Title
    Fusion rate
    Description
    subtalar fusion radiologically and clinically
    Time Frame
    3 month
    Secondary Outcome Measure Information:
    Title
    Functional assessment -rate of complications(e.g. non-union, post-operative infections, Instability) -secondary surgery procedures
    Description
    by AOFAS Ankle-Hindfoot Scale
    Time Frame
    3 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients who will be operated by subtalar fusion for any indication Age range 18 - 65 Exclusion Criteria: Age < 18 years , > 65 Acute calceneal fracture Infection Non union Bone defect that need bone graft Refusing to participate in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mahmoud M khalafallah, master
    Phone
    01117513794
    Email
    Mahmoud.20134334@med.aun.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wael Y El-adly, professor
    Phone
    01224265850
    Email
    eladlyw@aun.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31522872
    Citation
    Wirth SH, Viehofer A, Fritz Y, Zimmermann SM, Rigling D, Urbanschitz L. How many screws are necessary for subtalar fusion? A retrospective study. Foot Ankle Surg. 2020 Aug;26(6):699-702. doi: 10.1016/j.fas.2019.08.017. Epub 2019 Sep 6.
    Results Reference
    background
    PubMed Identifier
    8919403
    Citation
    Buch BD, Myerson MS, Miller SD. Primary subtaler arthrodesis for the treatment of comminuted calcaneal fractures. Foot Ankle Int. 1996 Feb;17(2):61-70. doi: 10.1177/107110079601700202.
    Results Reference
    background

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    Subtalar Arthrodesis by Single Versus Double Screws

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