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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Dynasplint Systems, Inc.

ClinicalTrials.gov Identifier:

NCT00717691

First received: July 15, 2008

Last updated: April 27, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 15, 2008

Last Updated Date

April 27, 2012

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hallux Limitus

Intervention ^ICMJE

Device: Metatarsophalangeal Extension Dynasplint System
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.
Other: Standard of Care
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.

Study Arm (s)

Experimental: 1
Immediate fitting with dynamic splinting following diagnosis of hallux limitus.
Interventions:
- Device: Metatarsophalangeal Extension Dynasplint System
- Other: Standard of Care
No Intervention: 2
Control arm; patients only treated with standard of care following diagnosis of hallux limitus.

Intervention: Other: Standard of Care

Publications *

Goucher NR, Coughlin MJ. Hallux metatarsophalangeal joint arthrodesis using dome-shaped reamers and dorsal plate fixation: a prospective study. Foot Ankle Int. 2006 Nov;27(11):869-76.
Hockenbury RT. Forefoot problems in athletes. Med Sci Sports Exerc. 1999 Jul;31(7 Suppl):S448-58. Review.
Willis B, John M. Dynamic Splinting Increases Flexion for Hallux Rigidus (Pilot Study). BioMechanics, 2007 Sept;14(9), pg49-53
Brodsky JW, Baum BS, Pollo FE, Mehta H. Prospective gait analysis in patients with first metatarsophalangeal joint arthrodesis for hallux rigidus. Foot Ankle Int. 2007 Feb;28(2):162-5.
Talarico LM, Vito GR, Goldstein L, Perler AD. Management of hallux limitus with distraction of the first metatarsophalangeal joint. J Am Podiatr Med Assoc. 2005 Mar-Apr;95(2):121-9.
Payne C, Chuter V, Miller K. Sensitivity and specificity of the functional hallux limitus test to predict foot function. J Am Podiatr Med Assoc. 2002 May;92(5):269-71.
Kennedy JG, Chow FY, Dines J, Gardner M, Bohne WH. Outcomes after interposition arthroplasty for treatment of hallux rigidus. Clin Orthop Relat Res. 2006 Apr;445:210-5.
DeFrino PF, Brodsky JW, Pollo FE, Crenshaw SJ, Beischer AD. First metatarsophalangeal arthrodesis: a clinical, pedobarographic and gait analysis study. Foot Ankle Int. 2002 Jun;23(6):496-502.
Canseco K, Long J, Marks R, Khazzam M, Harris G. Quantitative characterization of gait kinematics in patients with hallux rigidus using the Milwaukee foot model. J Orthop Res. 2008 Apr;26(4):419-27.
Becher C, Kilger R, Thermann H. Results of cheilectomy and additional microfracture techniques for the treatment of hallux rigidus. Foot Ankle Surg. 2005;(10): 155-160
Lau JT, Daniels TR. Outcomes following cheilectomy and interpositional arthroplasty in hallux rigidus. Foot Ankle Int. 2001 Jun;22(6):462-70.
Willis B. Dancers restore knee flexion through dynamic splinting. BioMechanics. 2008;Jan;15(1), pg49-54

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

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 Number ^ICMJE

NCT00717691

Other Study ID Numbers ^ICMJE

2008.003

Has Data Monitoring Committee

Yes

Responsible Party

Dynasplint Systems, Inc.

Study Sponsor ^ICMJE

Dynasplint Systems, Inc.

Collaborators ^ICMJE

Not Provided

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

April 2012

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

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