DRUJ: Treatment Options for Acute Distal Radioulnar Joint Instability

• Sponsor: Orlando Health, Inc. (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02591810
• Collaborator: (none)
• Enrollment: 0
• Arms: 3
• Actual Duration (Months): 12.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wrist Injuries	Procedure: Serial casting/splinting; Procedure: Percutaneous fixation; Procedure: Foveal repair	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Treatment Options for Acute Distal Radioulnar Joint Instability: A Prospective Randomized Control Trial
• Actual Study Start Date: Nov 5, 2015
• Actual Primary Completion Date: Nov 5, 2016
• Actual Study Completion Date: Nov 9, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Serial Casting 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; Serial Casting involves applying and removing a series of lightweight casts made of fiberglass. The wrist is monitored as healing occurs.
Active Comparator: Kirschner wires Participants will receive the intervention of percutaneous fixation with Kirschner wires for the injured wrist. This will be performed surgically.	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.
Active Comparator: Foveal repair 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; Injury is treated by open anatomic foveal repair of the ligaments. This is a surgical procedure.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Other Outcome Measures

1. Mayo wrist assessment scores [Up to 5 years]

   Patients will be asked to describe their pain intensity, range of motion, grip strength and functional status.

2. Patient satisfaction [Up to 5 years]

   Patients will be asked to describe on a scale from 1 to 10 how satisfied they are with their surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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. -

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Orlando Health, Inc.

Investigators

• Study Chair: Tara Roberts, BS, Orlando Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brett Lewellyn, Orthopedic surgeon, Hand specialist, Orlando Health, Inc.
• ClinicalTrials.gov Identifier: NCT02591810
• Other Study ID Numbers: 15.041.04
• First Posted: Oct 30, 2015
• Last Update Posted: Oct 2, 2017
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Joint Instability; Wrist Injuries

Study Results

No Results Posted as of Oct 2, 2017