Treatment Options for Acute Distal Radioulnar Joint Instability

Wrist Injuries Clinical Trial

— DRUJ  

Official title:

Comparison of Treatment Options for Acute Distal Radioulnar Joint Instability: A Prospective Randomized Control Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02591810
• Other study ID #: 15.041.04
• Status: Withdrawn
• Phase: N/A
• First received: July 22, 2015
• Last updated: September 29, 2017
• Start date: November 5, 2015
• Est. completion date: November 9, 2016

Study information

• Verified date: September 2017
• Source: Orlando Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 9, 2016
• Est. primary completion date: November 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Joint Instability
• Wrist Injuries

Intervention

Procedure:
• Serial casting/splinting
Serial Casting involves applying and removing a series of lightweight casts made of fiberglass. The wrist is monitored as healing occurs.
• Percutaneous fixation
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.
• Foveal repair
Injury is treated by open anatomic foveal repair of the ligaments. This is a surgical procedure.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Orlando Health, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mayo wrist assessment scores	Patients will be asked to describe their pain intensity, range of motion, grip strength and functional status.	Up to 5 years
Other	Patient satisfaction	Patients will be asked to describe on a scale from 1 to 10 how satisfied they are with their surgery.	Up to 5 years
Primary	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.	Up to 5 years.
Secondary	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.	Up to 5 years.