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

Hallux Limitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717691
• Other study ID #: 2008.003
• Status: Completed
• Phase: N/A
• First received: July 15, 2008
• Last updated: April 27, 2012
• Start date: July 2008
• Est. completion date: December 2008

Study information

• Verified date: April 2012
• Source: Dynasplint Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hallux Limitus
• Hallux Rigidus

Intervention

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.

Locations

Country	Name	City	State
United States	Atlanta Foot and Leg Clinic	Jonesboro	Georgia
United States	Ankle and Foot Centers, PC	Marietta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Dynasplint Systems, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (12)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hockenbury RT. Forefoot problems in athletes. Med Sci Sports Exerc. 1999 Jul;31(7 Suppl):S448-58. Review. — View Citation

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. — View Citation

Lau JT, Daniels TR. Outcomes following cheilectomy and interpositional arthroplasty in hallux rigidus. Foot Ankle Int. 2001 Jun;22(6):462-70. — View Citation

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. — View Citation

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. — View Citation

Willis B, John M. Dynamic Splinting Increases Flexion for Hallux Rigidus (Pilot Study). BioMechanics, 2007 Sept;14(9), pg49-53

Willis B. Dancers restore knee flexion through dynamic splinting. BioMechanics. 2008;Jan;15(1), pg49-54

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Active Range of Motion of Hallux (great toe) Extension		Two Months	No
Secondary	Change in passive Range of Motion, Extension		same	No