Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial - Tabular View

Tracking Information

First Received Date ^ICMJE

July 15, 2008

Last Updated Date

June 5, 2009

Start Date ^ICMJE

July 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Active Range of Motion of Hallux (great toe) Extension [ Time Frame: Two Months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00717691 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in passive Range of Motion, Extension [ Time Frame: same ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial

Official Title ^ICMJE

Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial

Brief 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.

Detailed Description

Determine the efficacy of dynamic splinting in treating patients with hallux limitus, in a randomized, controlled trial.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Single Group Assignment

Condition ^ICMJE

Hallux Limitus

Intervention ^ICMJE

Device: Metatarsophalangeal Extension Dynasplint System
Other: Standard of Care

Study Arms / Comparison Groups

Experimental: Immediate fitting with dynamic splinting following diagnosis of hallux limitus.
No Intervention: Control arm; patients only treated with standard of care following diagnosis of hallux limitus.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Reduced flexibility in AROM of extension in the great toe
Pain that is worsened by walking and/or squatting
Impaired gait pattern

Exclusion Criteria:

Metatarsal stress fracture
Interdigital neuroma
Sesamoid pathology
Gout
Metatarsalgia

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00717691

Responsible Party

Buck Willis, PhD: Clinical Research Director, Dynasplint Systems, Inc.

Study ID Numbers ^ICMJE

2008.003

Study Sponsor ^ICMJE

Dynasplint Systems, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Stanley R Kalish, DPM, FACFAS	Atlanta Foot and Leg Clinic
Study Director:	Buck Willis, PhD	Dynasplint Systems, Inc.

Information Provided By

Dynasplint Systems, Inc.

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP