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Distraction Osteogenesis for Distal Radius Fractures vs. Volar Plating

NCT03635060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-05-03

No results posted yet for this study

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

Interventions

PROCEDURE

Dorsal Bridge Plating

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.

PROCEDURE

Volar locking plating

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.

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Patrick Henry · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-12
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03635060 on ClinicalTrials.gov