CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Conventus DRS +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02390856
NCT02390856N/ACompleted
CompareCT.gov

Randomized Controlled Trial: Volar Plate vs. Conventus DRS Intramedullary Fixation for Distal Radius Fractures

Hospital for Special Surgery, New York·interventional·Posted Mar 18, 2015·Updated Feb 8, 2019

In Brief

A clinical study evaluating Conventus DRS and Volar Plate for Fractures, Closed. Completed, enrolled 12 participants across 1 site.

Detailed Summary

Open reduction and internal fixation (ORIF) of unstable distal radius fractures is performed using a variety of fixation techniques. The most common method is fixed angle volar plate application. The investigators plan to compare the outcomes of fixed angle volar plating with a novel FDA approved intramedullary fixation device, Conventus DRS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFractures, Closed
CountriesUnited States
CollaboratorsConventus Orthopaedics, Inc.

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 18, 2015
Enrollment StartFeb 1, 2015
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.3 years ago

Interventions

Conventus DRSdevice

The Conventus DRS (TM) is an intramedullary device intended to treat distal radius fractures. The device remains flexible during placement, but is made rigid at the completion of the surgical implant procedure. The implant is made from titanium alloy (Ti-6A1-4V) and Nitinol.

Volar Platedevice

A volar plate is a metallic plate fastened directly to the fractured bone with screws, to hold the fracture fragments in proper position. Volar plate fixation is the traditional surgical method for distal radius fractures.