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Treatment Options for Acute Distal Radioulnar Joint Instability (DRUJ)

Primary Purpose

Wrist Injuries

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Serial casting/splinting
Percutaneous fixation
Foveal repair
Sponsored by
Orlando Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wrist Injuries

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients treated at Orlando Regional Medical Center,
  2. 18 years or older,
  3. Have an acute (less than 4 week old) injury with instability of the DRUJ.

Exclusion Criteria:

  1. Younger than 18 years old,
  2. Patients with an injury over 4 weeks old,
  3. Previous history of ipsilateral upper extremity trauma,
  4. Functional deficit,
  5. Those who are unable to complete postoperative assessments. -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Serial Casting

    Kirschner wires

    Foveal repair

    Arm Description

    Participants will receive the intervention of the placement of serial casting/splinting for the injured wrist. This is not a surgical intervention.

    Participants will receive the intervention of percutaneous fixation with Kirschner wires for the injured wrist. This will be performed surgically.

    Participants will receive the intervention of open anatomic foveal repair of the ligaments of the injured wrist. This is a surgical intervention.

    Outcomes

    Primary Outcome Measures

    Evaluation and assessment of DASH scores.
    To compare the outcomes of the three treatment arms for acute DRUJ instability by assessment with the Disabilities of the Arm, Shoulder, and Hand (DASH) Score.

    Secondary Outcome Measures

    Visual Analog Pain scale
    Patient will be asked to describe level on pain on a 10cm scale, in 1 cm increments, from 0 to 10. 0 equals no pain, 10 equals the worst pain.

    Full Information

    First Posted
    July 22, 2015
    Last Updated
    September 29, 2017
    Sponsor
    Orlando Health, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02591810
    Brief Title
    Treatment Options for Acute Distal Radioulnar Joint Instability
    Acronym
    DRUJ
    Official Title
    Comparison of Treatment Options for Acute Distal Radioulnar Joint Instability: A Prospective Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    November 5, 2015 (Actual)
    Primary Completion Date
    November 5, 2016 (Actual)
    Study Completion Date
    November 9, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Orlando Health, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This prospective randomized control trial (PRCT) aims to compare the outcome of three treatments for acute distal radioulnar joint (DRUJ) injury with instability with or without concomitant distal radius fractures: serial splinting/casting with the hand and wrist in the most stable position for DRUJ reduction vs percutaneous DRUJ fixation with Kirschner wires vs open anatomic foveal repair of Triangular fibrocartilage complex (TFCC ) ligaments.
    Detailed Description
    This is a prospective randomized control trial comparing three methods of treatment for acute DRUJ instability with or without concomitant distal radius fracture. Upon determination of residual DRUJ instability either preoperatively or intraoperatively after distal radius fracture fixation, patients will be randomized into one of the three treatment arms of the study: nonoperative treatment with immobilization, percutaneous DRUJ fixation with Kirschner wires, and open anatomic foveal repair of Triangular fibrocartilage complex TFCC ligaments with suture. Those patients undergoing Kirschner wire fixation will have their pins pulled in the clinic setting six weeks postoperatively. Outcomes will be assessed at follow up visits using the subjective and objective measures and clinical assistants will be blinded as to the treatment type. Physician-based assessment of functional outcome with be assessed using the Disability of the Arm, Shoulder and Hand (DASH) score and Mayo Wrist scores, as well as independent assessment of DRUJ instability, ROM, and grip strength. Patient-based assessment will include visual analog pain scores as well as satisfaction questionnaires.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wrist Injuries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Serial Casting
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive the intervention of the placement of serial casting/splinting for the injured wrist. This is not a surgical intervention.
    Arm Title
    Kirschner wires
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive the intervention of percutaneous fixation with Kirschner wires for the injured wrist. This will be performed surgically.
    Arm Title
    Foveal repair
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive the intervention of open anatomic foveal repair of the ligaments of the injured wrist. This is a surgical intervention.
    Intervention Type
    Procedure
    Intervention Name(s)
    Serial casting/splinting
    Intervention Description
    Serial Casting involves applying and removing a series of lightweight casts made of fiberglass. The wrist is monitored as healing occurs.
    Intervention Type
    Procedure
    Intervention Name(s)
    Percutaneous fixation
    Intervention Description
    Injury is treated by the percutaneous placement of Kirschner wires to promote healing. This is an invasive procedure, involving the placement of Kirschner wires to stabilize the wrist.
    Intervention Type
    Procedure
    Intervention Name(s)
    Foveal repair
    Intervention Description
    Injury is treated by open anatomic foveal repair of the ligaments. This is a surgical procedure.
    Primary Outcome Measure Information:
    Title
    Evaluation and assessment of DASH scores.
    Description
    To compare the outcomes of the three treatment arms for acute DRUJ instability by assessment with the Disabilities of the Arm, Shoulder, and Hand (DASH) Score.
    Time Frame
    Up to 5 years.
    Secondary Outcome Measure Information:
    Title
    Visual Analog Pain scale
    Description
    Patient will be asked to describe level on pain on a 10cm scale, in 1 cm increments, from 0 to 10. 0 equals no pain, 10 equals the worst pain.
    Time Frame
    Up to 5 years.
    Other Pre-specified Outcome Measures:
    Title
    Mayo wrist assessment scores
    Description
    Patients will be asked to describe their pain intensity, range of motion, grip strength and functional status.
    Time Frame
    Up to 5 years
    Title
    Patient satisfaction
    Description
    Patients will be asked to describe on a scale from 1 to 10 how satisfied they are with their surgery.
    Time Frame
    Up to 5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients treated at Orlando Regional Medical Center, 18 years or older, Have an acute (less than 4 week old) injury with instability of the DRUJ. Exclusion Criteria: Younger than 18 years old, Patients with an injury over 4 weeks old, Previous history of ipsilateral upper extremity trauma, Functional deficit, Those who are unable to complete postoperative assessments. -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tara Roberts, BS
    Organizational Affiliation
    Orlando Health
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment Options for Acute Distal Radioulnar Joint Instability

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