Treatment Options for Acute Distal Radioulnar Joint Instability

Not Applicable

Withdrawn

• Conditions: Wrist Injuries
• Interventions: Procedure: Percutaneous fixation; Procedure: Serial casting/splinting; Procedure: Foveal repair

• Registration Number: NCT02591810
• Lead Sponsor: Orlando Health, Inc.

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.

Study Timeline

• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-30
• Study Start: 2015-11-05
• Primary Completion: 2016-11-05
• Study Completion: 2016-11-09
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-29
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kirschner wires	Percutaneous fixation	Participants will receive the intervention of percutaneous fixation with Kirschner wires for the injured wrist. This will be performed surgically.
Serial Casting	Serial casting/splinting	Participants will receive the intervention of the placement of serial casting/splinting for the injured wrist. This is not a surgical intervention.
Foveal repair	Foveal repair	Participants will receive the intervention of open anatomic foveal repair of the ligaments of the injured wrist. This is a surgical intervention.

Primary Outcome Measures

Name	Time	Method
Evaluation and assessment of DASH scores.	Up to 5 years.	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

Name	Time	Method
Visual Analog Pain scale	Up to 5 years.	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.