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Withdrawn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
About this trial
This is an interventional treatment trial for Wrist Injuries
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. -
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
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Withdrawn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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