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

Sponsor:	Dynasplint Systems, Inc.
Information provided by:	Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:	NCT00717691

Purpose

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.

Condition	Intervention
Hallux Limitus	Device: Metatarsophalangeal Extension Dynasplint System Other: Standard of Care

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Foot Health

U.S. FDA Resources

Further study details as provided by Dynasplint Systems, Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	50
Study Start Date:	July 2008
Study Completion Date:	December 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Immediate fitting with dynamic splinting following diagnosis of hallux limitus.	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.
No Intervention: 2 Control arm; patients only treated with standard of care following diagnosis of hallux limitus.	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.

Arms

Assigned Interventions

Experimental: 1

Immediate fitting with dynamic splinting following diagnosis of hallux limitus.

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.

No Intervention: 2

Control arm; patients only treated with standard of care following diagnosis of hallux limitus.

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.

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717691

Locations

United States, Georgia
Atlanta Foot and Leg Clinic
Jonesboro, Georgia, United States, 30236
Ankle and Foot Centers, PC
Marietta, Georgia, United States, 30066

Sponsors and Collaborators

Dynasplint Systems, Inc.

Investigators

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

More Information

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

Responsible Party:	Buck Willis, PhD: Clinical Research Director, Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:	NCT00717691 History of Changes
Other Study ID Numbers:	2008.003
Study First Received:	July 15, 2008
Last Updated:	June 5, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Dynasplint Systems, Inc.:

Hallux Limitus
Dynamic Splinting
Dynasplint

Additional relevant MeSH terms:

Hallux Limitus
Hallux Rigidus
Foot Deformities, Acquired

Foot Deformities
Musculoskeletal Diseases
Joint Diseases

ClinicalTrials.gov processed this record on February 12, 2012