CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 108 enrolled
Drug / intervention
reamed, interlocking intramedullary nail +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/NCT00429585
NCT00429585N/ACompleted
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Intramedullary Nail Versus Plate Fixation Re-Evaluation Study in Proximal Tibial Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation (IMPRESS)

Boston Medical Center·interventional·Posted Feb 1, 2007·Updated Nov 2, 2021

In Brief

A clinical study evaluating reamed, interlocking intramedullary nail and locking periarticular plate for Tibial Fractures. Completed, enrolled 108 participants across 29 sites in 2 countries.

Detailed Summary

This study looks at two types of surgical treatments and hopes to answer the question: which is the best way to surgically treat a proximal tibia fracture? Both procedures being studied are standard of care (used routinely) and use FDA approved devices. All medical and surgical treatment will be the same for participants as non-participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTibial Fractures
CountriesCanada, United States
CollaboratorsOrthopaedic Trauma Association

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 1, 2007
Enrollment StartFeb 1, 2007
Primary CompletionNov 30, 2020
Study CompletionDec 16, 2020
TodayJul 2, 2026
Enrollment to primary: 13.8 yearsPosted 19.4 years ago

Interventions

reamed, interlocking intramedullary naildevice

Standard of care device for tibia fracture repair; Randomized Treatment - Nail

locking periarticular platedevice

Standard of care device for tibia fracture repair; Randomized Treatment - Plate