Back to resultsHallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial
Primary Purpose
Hallux Limitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Metatarsophalangeal Extension Dynasplint System
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Hallux Limitus focused on measuring Hallux Limitus, Dynamic Splinting, Dynasplint
Eligibility 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
Sites / Locations
- Atlanta Foot and Leg Clinic
- Ankle and Foot Centers, PC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Immediate fitting with dynamic splinting following diagnosis of hallux limitus.
Control arm; patients only treated with standard of care following diagnosis of hallux limitus.
Outcomes
Primary Outcome Measures
Change in Active Range of Motion of Hallux (great toe) Extension
Secondary Outcome Measures
Change in passive Range of Motion, Extension
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00717691
Brief Title
Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial
Official Title
Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynasplint Systems, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Limitus
Keywords
Hallux Limitus, Dynamic Splinting, Dynasplint
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Immediate fitting with dynamic splinting following diagnosis of hallux limitus.
Arm Title
2
Arm Type
No Intervention
Arm Description
Control arm; patients only treated with standard of care following diagnosis of hallux limitus.
Intervention Type
Device
Intervention Name(s)
Metatarsophalangeal Extension Dynasplint System
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Active Range of Motion of Hallux (great toe) Extension
Time Frame
Two Months
Secondary Outcome Measure Information:
Title
Change in passive Range of Motion, Extension
Time Frame
same
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley R Kalish, DPM, FACFAS
Organizational Affiliation
Atlanta Foot and Leg Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Buck Willis, PhD
Organizational Affiliation
Dynasplint Systems, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Atlanta Foot and Leg Clinic
City
Jonesboro
State/Province
Georgia
ZIP/Postal Code
30236
Country
United States
Facility Name
Ankle and Foot Centers, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17144945
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. doi: 10.1177/107110070602701101.
Results Reference
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PubMed Identifier
10416546
Citation
Hockenbury RT. Forefoot problems in athletes. Med Sci Sports Exerc. 1999 Jul;31(7 Suppl):S448-58. doi: 10.1097/00005768-199907001-00006.
Results Reference
background
Citation
Willis B, John M. Dynamic Splinting Increases Flexion for Hallux Rigidus (Pilot Study). BioMechanics, 2007 Sept;14(9), pg49-53
Results Reference
background
PubMed Identifier
17296132
Citation
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.
Results Reference
background
PubMed Identifier
15778469
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. doi: 10.7547/0950121.
Results Reference
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PubMed Identifier
12015407
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. doi: 10.7547/87507315-92-5-269.
Results Reference
background
PubMed Identifier
16467621
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. doi: 10.1097/01.blo.0000201166.82690.23.
Results Reference
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PubMed Identifier
12095117
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. doi: 10.1177/107110070202300605.
Results Reference
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PubMed Identifier
17972321
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. doi: 10.1002/jor.20506.
Results Reference
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Citation
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
Results Reference
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PubMed Identifier
11475452
Citation
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.
Results Reference
background
Citation
Willis B. Dancers restore knee flexion through dynamic splinting. BioMechanics. 2008;Jan;15(1), pg49-54
Results Reference
background
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Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial
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