CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Metatarsophalangeal Extension Dynasplint System +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/NCT00717691
NCT00717691N/ACompleted
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Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial

Dynasplint Systems, Inc.·interventional·Posted Jul 17, 2008·Updated Apr 30, 2012

In Brief

A clinical study evaluating Metatarsophalangeal Extension Dynasplint System and Standard of Care for Hallux Limitus. Completed, enrolled 50 participants across 2 sites.

Detailed Summary

The purpose of this study is to regain range of motion of the great toe with dynamic splinting which will help reduce great toe's pain and swelling.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHallux Limitus
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 17, 2008
Enrollment StartJul 1, 2008
Primary CompletionOct 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 18.0 years ago

Interventions

Metatarsophalangeal Extension Dynasplint Systemdevice

Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn for 30 minutes, three times per day, (while seated or resting in bed) totaling 1.5 hours per day.

Standard of Careother

The current standard of care in treating Hallux Limitus will be given to all patients regardless of randomized categorization, and this includes: analgesic and nonsteroidal anti-inflammatory drugs (NSAIDs), orthotics with medial stiffness, and reduction of great toe movement in motions such as kneeling or squatting with the toes in an extended position.