NCT02591810

Treatment Options for Acute Distal Radioulnar Joint Instability

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Orlando Health, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wrist Injuries

Interventions

Type	Name	Description
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.
PROCEDURE	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.
PROCEDURE	Foveal repair	Injury is treated by open anatomic foveal repair of the ligaments. This is a surgical procedure.

Timeline

• Start date: 2015-11-05
• Primary completion: 2016-11-05
• Completion: 2016-11-09
• First posted: 2015-10-30
• Last updated: 2025-08-05