Distraction Osteogenesis for Distal Radius Fractures vs. Volar Plating

NCT03635060 | Completed

• 1 other identifier: DORSAL
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Optimal fixation for highly comminuted distal radius fractures with metadiaphyseal extension remains to be a major treatment challenge for orthopaedic surgeons. The purpose of this study is to determine the safety, feasibility and sample size estimations for a larger, definitive study comparing functional outcomes of patients treated with dorsal distraction plate fixation with or without fragment specific fixation to standard open reduction internal fixation in highly comminuted distal radius fractures (subtypes AO.23-C2 and AO.23-C3). The study design will be a pilot randomized control trial. Fracture pattern eligibility will be determined by consensus agreement between two fellowship trained upper extremity specialists. The primary outcome measure will be the QuickDASH score. Secondary outcome measures include wrist range of motion, grip strength, Visual Analog Scale pain scale, Short Form SF-12, and EQ-5D. Ultimately, this study will lead to a larger randomized control trial and result in improvement in the care and treatment of patients with these challenging injuries.

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

• QuickDASH

  It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity level/ function level.

  primary outcome assessed at 1 year following surgery (survey done at each followup starting at week 6)

Secondary Outcomes (2)

• Change in Patient-Related Wrist Evaluation

  2 weeks, 6 weeks, 3 months, 6 months, and 1 year following surgery

• EQ-5D

  6 weeks, 3 months, 6 months, and 1 year following surgery

Other Outcomes (4)

• Range of Motion

  3 months, 6 months, and 1 year following surgery

• Grip Strength

  6 weeks, 3 months, 6 months, and 1 year following surgery

• Anterior-posterior x-rays

  2 weeks, 6 weeks, 3 months, 6 months, and 1 year following surgery

Study Arms (2)

Dorsal Bridge Plating

ACTIVE COMPARATOR

The intervention is surgery with dorsal distraction plating with or without any additional fragment specific fixation.

Procedure: Dorsal Bridge Plating

Volar Locking Plating

ACTIVE COMPARATOR

The intervention is surgery with open reduction and internal fixation with non-spanning fixation.

Procedure: Volar locking plating

Interventions

Dorsal Bridge Plating PROCEDURE

This study will be a pilot randomized control trial that will focus on treating patients with the described fracture pattern either with dorsal distraction plating with or without any additional fragment specific fixation or standard open reduction internal fixation.

Dorsal Bridge Plating

Volar locking plating PROCEDURE

This study will be a pilot randomized control trial that will focus on treating patients with the described fracture pattern either with dorsal distraction plating with or without any additional fragment specific fixation or standard open reduction internal fixation.

Volar Locking Plating

Eligibility Criteria

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

You may qualify if:

• Men and women over the age of 18 years
• Diagnosed with unilateral or bilateral, open or closed, severely comminuted distal radius fractures (fracture classification of AO.23-C2 and AO.23-C3)
• Scheduled to undergo surgery

You may not qualify if:

• Previous wrist injuries or surgery that would compromise performance of either procedure.
• Surgery delayed beyond 21 days from injury.
• Significant medical comorbidities.
• Neurologic injury causing paralysis of affected arm.
• Those unable to attend follow up and comply with the post-operative protocol

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Patrick Henry

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 17, 2018
• Study Start: September 12, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)