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Hematoma Distraction Arthroplasty Versus Arthroscopic Trapeziectomy in Basal Thumb Arthritis

Primary Purpose

Orthopedic Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
wrist arthroscopy
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Orthopedic Disorder

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age: adult patient > 20years. Gender: Males & Females. Symptomtic patient. Failed conservative treatment of 6 months duration Eaton stage II, III and IV of base thumb arthritis Exclusion Criteria: Patient presenting with flexor carpi radialis rupture Previous Zancolli arthroplasty Associated comorbidity as: RA,DM with joint destruction Infection Poor Skin Condition Active Pateint With High Joint Demand

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Hematoma distraction

    Arthroscopic

    Arm Description

    open Hematoma distraction

    Arthroscopic Partial Trapeziectomy with Hematoma Distraction

    Outcomes

    Primary Outcome Measures

    DASH score
    score for pinch grip

    Secondary Outcome Measures

    Full Information

    First Posted
    February 17, 2023
    Last Updated
    February 17, 2023
    Sponsor
    Al-Azhar University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05746091
    Brief Title
    Hematoma Distraction Arthroplasty Versus Arthroscopic Trapeziectomy in Basal Thumb Arthritis
    Official Title
    Hematoma Distraction Arthroplasty Versus Arthroscopic Partial Trapeziectomy With Hematoma Distraction in Basal Thumb Arthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    March 2025 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Al-Azhar 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
    The basal joint, also referred to as the carpometacarpal (CMC) joint, of the thumb is one of the joints most commonly affected by arthritis. CMC joint arthritis can lead to decreased grip and pinch strength and impairment of activities of daily living
    Detailed Description
    The thumb CMC joint has been reported as the most painful joint when compared to other hand joints affected by OA. It is therefore no surprise that this is a common chief complaint of patients and has a significant effect on work and life satisfaction Patients often present with complaints of pain localized to the base of the thumb that is exacerbated when performing tasks such as opening a jar, turning a car key, and turning door Knob, this pain may be reproduced by resisted pinch and grip . On physical examination, patients will have point tenderness at the thumb basal joint with swelling and crepitus when the basal joint is compressed - a positive grind test and a positive "hump" sign from dorsal CMC dislocation subluxation .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Orthopedic Disorder

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hematoma distraction
    Arm Type
    Active Comparator
    Arm Description
    open Hematoma distraction
    Arm Title
    Arthroscopic
    Arm Type
    Active Comparator
    Arm Description
    Arthroscopic Partial Trapeziectomy with Hematoma Distraction
    Intervention Type
    Procedure
    Intervention Name(s)
    wrist arthroscopy
    Intervention Description
    Hematoma Distraction Arthroplasty Versus Arthroscopic Partial Trapeziectomy with Hematoma Distraction in Basal Thumb Arthritis
    Primary Outcome Measure Information:
    Title
    DASH score
    Description
    score for pinch grip
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age: adult patient > 20years. Gender: Males & Females. Symptomtic patient. Failed conservative treatment of 6 months duration Eaton stage II, III and IV of base thumb arthritis Exclusion Criteria: Patient presenting with flexor carpi radialis rupture Previous Zancolli arthroplasty Associated comorbidity as: RA,DM with joint destruction Infection Poor Skin Condition Active Pateint With High Joint Demand
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maysara Mohammed, MD
    Phone
    0201063119673
    Email
    maysarabayoumy.216@Azhar.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Abbas, MD
    Phone
    0201067715777
    Email
    ahmedabbasmahmoud680@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Hematoma Distraction Arthroplasty Versus Arthroscopic Trapeziectomy in Basal Thumb Arthritis

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