Treatment Options for Acute Distal Radioulnar Joint Instability

NCT ID: NCT02591810

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-05
• Study Completion Date: 2016-11-09

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.

Conditions

Wrist Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Serial Casting

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

Group Type: ACTIVE_COMPARATOR

Serial casting/splinting

Intervention Type: PROCEDURE

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

Kirschner wires

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

Group Type: ACTIVE_COMPARATOR

Percutaneous fixation

Intervention Type: 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.

Foveal repair

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

Group Type: ACTIVE_COMPARATOR

Foveal repair

Intervention Type: PROCEDURE

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

Interventions

Serial casting/splinting

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Foveal repair

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

Intervention Type: PROCEDURE

Eligibility Criteria

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. -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orlando Health, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Brett Lewellyn

Orthopedic surgeon, Hand specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tara Roberts, BS

Role: STUDY_CHAIR

Orlando Health

Other Identifiers

15.041.04

Identifier Type: -

Identifier Source: org_study_id