Treatment Options for Acute Distal Radioulnar Joint Instability

NCT02591810 | Withdrawn

• 1 other identifier: 15.041.04
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wrist Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visual Analog Pain scale

  Up to 5 years.

Other Outcomes (2)

• Mayo wrist assessment scores

  Up to 5 years

• Patient satisfaction

  Up to 5 years

Study Arms (3)

Serial Casting

ACTIVE COMPARATOR

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

Procedure: Serial casting/splinting

Kirschner wires

ACTIVE COMPARATOR

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

Procedure: Percutaneous fixation

Foveal repair

ACTIVE COMPARATOR

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

Procedure: Foveal repair

Interventions

Serial casting/splinting PROCEDURE

Serial Casting involves applying and removing a series of lightweight casts made of fiberglass. The wrist is monitored as healing occurs.

Serial Casting

Percutaneous fixation PROCEDURE

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.

Kirschner wires

Foveal repair PROCEDURE

Injury is treated by open anatomic foveal repair of the ligaments. This is a surgical procedure.

Foveal repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Orlando Health, Inc.: lead

MeSH Terms

Conditions

Wrist Injuries

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries

Study Officials

• Tara Roberts, BS

  Orlando Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic surgeon, Hand specialist

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: October 30, 2015
• Study Start: November 5, 2015
• Primary Completion: November 5, 2016
• Study Completion: November 9, 2016
• Last Updated: August 5, 2025

Record last verified: 2025-07