Treatment Options for Acute Distal Radioulnar Joint Instability (DRUJ)

Orlando Health, Inc.

Status: Withdrawn

Conditions: Wrist Injuries

Treatments: Procedure: Serial casting/splinting; Procedure: Percutaneous fixation; Procedure: Foveal repair

Study type: Interventional

Funder types: Other

Identifiers

NCT02591810

15.041.04

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups

Serial Casting

Active Comparator group

Description:

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

Treatment:

Procedure: Serial casting/splinting

Kirschner wires

Active Comparator group

Description:

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

Treatment:

Procedure: Percutaneous fixation

Foveal repair

Active Comparator group

Description:

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

Treatment:

Procedure: Foveal repair