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

NCT00717691 | Completed DMC

• 1 other identifier: 2008.003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Hallux Limitus

Keywords

Hallux Limitus; Dynamic Splinting; Dynasplint

Outcome Measures

Primary Outcomes (1)

• Change in Active Range of Motion of Hallux (great toe) Extension

  Two Months

Secondary Outcomes (1)

• Change in passive Range of Motion, Extension

  same

Study Arms (2)

1

EXPERIMENTAL

Immediate fitting with dynamic splinting following diagnosis of hallux limitus.

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

2

NO INTERVENTION

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

Other: Standard of Care

Interventions

Metatarsophalangeal Extension Dynasplint System DEVICE

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.

1

Standard of Care OTHER

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.

1; 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Metatarsal stress fracture
• Interdigital neuroma
• Sesamoid pathology
• Gout
• Metatarsalgia

Sponsors & Collaborators

• Dynasplint Systems, Inc.: lead

Study Sites (2)

Atlanta Foot and Leg Clinic

Jonesboro, Georgia, 30236, United States

Location

Ankle and Foot Centers, PC

Marietta, Georgia, 30066, United States

Location

Related Publications (12)

• 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. doi: 10.1177/107110070602701101.

  PMID: 17144945 BACKGROUND

• Hockenbury RT. Forefoot problems in athletes. Med Sci Sports Exerc. 1999 Jul;31(7 Suppl):S448-58. doi: 10.1097/00005768-199907001-00006.

  PMID: 10416546 BACKGROUND

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

  BACKGROUND

• 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. doi: 10.3113/FAI.2007.0162.

  PMID: 17296132 BACKGROUND

• 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. doi: 10.7547/0950121.

  PMID: 15778469 BACKGROUND

• 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. doi: 10.7547/87507315-92-5-269.

  PMID: 12015407 BACKGROUND

• 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. doi: 10.1097/01.blo.0000201166.82690.23.

  PMID: 16467621 BACKGROUND

• 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. doi: 10.1177/107110070202300605.

  PMID: 12095117 BACKGROUND

• 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. doi: 10.1002/jor.20506.

  PMID: 17972321 BACKGROUND

• 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

  BACKGROUND

• Lau JT, Daniels TR. Outcomes following cheilectomy and interpositional arthroplasty in hallux rigidus. Foot Ankle Int. 2001 Jun;22(6):462-70. doi: 10.1177/107110070102200602.

  PMID: 11475452 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Hallux Limitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Joint Diseases; Foot Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Stanley R Kalish, DPM, FACFAS

  Atlanta Foot and Leg Clinic

  PRINCIPAL INVESTIGATOR

• Buck Willis, PhD

  Dynasplint Systems, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 17, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 30, 2012

Record last verified: 2012-04

Locations

US (2)