Hallux LimitusNCT00717691
Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial
A study testing Metatarsophalangeal Extension Dynasplint System in people with Hallux Limitus, run by Dynasplint Systems, Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hallux Limitus
- What is being tested?
- Metatarsophalangeal Extension Dynasplint System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reduced flexibility in AROM of extension in the great toe
- Pain that is worsened by walking and/or squatting
- Impaired gait pattern
Who cannot join
- Metatarsal stress fracture
- Interdigital neuroma
- Sesamoid pathology
- Gout
- Metatarsalgia
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atlanta Foot and Leg Clinic
Jonesboro, Georgia, 30236
Ankle and Foot Centers, PC
Marietta, Georgia, 30066
About this study
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.
Read the detailed description
Determine the efficacy of dynamic splinting in treating patients with hallux limitus, in a randomized, controlled trial.
- Conditions
- Hallux Limitus
- Being tested
- Metatarsophalangeal Extension Dynasplint System, Standard of Care
- Keywords
- Hallux Limitus, Dynamic Splinting, Dynasplint
- Medical subject headings
- Hallux Limitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metatarsophalangeal Extension Dynasplint SystemDevice
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.
Standard of CareOther
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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Immediate fitting with dynamic splinting following diagnosis of hallux limitus. Receives: 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Active Range of Motion of Hallux (great toe) Extension
Measured: Two Months
Secondary outcomes (1)
Change in passive Range of Motion, Extension
Measured: same
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hallux LimitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynasplint Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stanley R Kalish, DPM, FACFAS, Principal investigator, Atlanta Foot and Leg ClinicBuck Willis, PhD, Study director, Dynasplint Systems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717691
- Sponsor's protocol ID
- 2008.003
- Status last verified
- Apr 2012
- First submitted
- 15 Jul 2008
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1177/107110070602701101.
PubMed 17144945Hockenbury RT. Forefoot problems in athletes. Med Sci Sports Exerc. 1999 Jul;31(7 Suppl):S448-58. doi: 10.1097/00005768-199907001-00006.
PubMed 10416546Willis 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. doi: 10.3113/FAI.2007.0162.
PubMed 17296132Talarico 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.
PubMed 15778469Payne 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.
PubMed 12015407Kennedy 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.
PubMed 16467621DeFrino 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.
PubMed 12095117Canseco 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.
PubMed 17972321Becher 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. doi: 10.1177/107110070102200602.
PubMed 11475452Willis B. Dancers restore knee flexion through dynamic splinting. BioMechanics. 2008;Jan;15(1), pg49-54
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00717691
- Acronym / sponsor ID
- 2008.003
- Conditions
- Hallux Limitus
- Keywords
- Hallux Limitus, Dynamic Splinting, Dynasplint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dynasplint Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 17 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Metatarsophalangeal Extension Dynasplint System, Other: Standard of CareImmediate fitting with dynamic splinting following diagnosis of hallux limitus. |
| 2 | No intervention | Other: Standard of CareControl arm; patients only treated with standard of care following diagnosis of hallux limitus. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Reduced flexibility in AROM of extension in the great toe
- Pain that is worsened by walking and/or squatting
- Impaired gait pattern
Key exclusion criteria (5 listed)
- Metatarsal stress fracture
- Interdigital neuroma
- Sesamoid pathology
- Gout
- Metatarsalgia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metatarsophalangeal Extension Dynasplint SystemDynamic 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. | Device | 1 |
| Standard of CareThe 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. | Other | 1, 2 |
Primary outcome
Change in Active Range of Motion of Hallux (great toe) Extension
Time frame: Two Months
1 secondary outcome
Change in passive Range of Motion, Extension
Time frame: same
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
- Background: PubMed 17144945Goucher 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.
- Background: PubMed 10416546Hockenbury RT. Forefoot problems in athletes. Med Sci Sports Exerc. 1999 Jul;31(7 Suppl):S448-58. doi: 10.1097/00005768-199907001-00006.
- BackgroundWillis B, John M. Dynamic Splinting Increases Flexion for Hallux Rigidus (Pilot Study). BioMechanics, 2007 Sept;14(9), pg49-53
- Background: PubMed 17296132Brodsky 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.
- Background: PubMed 15778469Talarico 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.
- Background: PubMed 12015407Payne 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.
- Background: PubMed 16467621Kennedy 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.
- Background: PubMed 12095117DeFrino 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.
- Background: PubMed 17972321Canseco 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.
- BackgroundBecher 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: PubMed 11475452Lau 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.
- BackgroundWillis B. Dancers restore knee flexion through dynamic splinting. BioMechanics. 2008;Jan;15(1), pg49-54
Related trials for Hallux Limitus
Active, not recruiting
The Hyalex MTP Study
Hallux Valgus, Hallux Limitus
Recruiting
Kinetic Control Versus Dynamic Taping on First Metatarsophalangeal Joint in Athletes With Functional Hallux Limitus
Hallux Limitus
Not yet recruiting
Effect of Foot Core Control Training on Dorsiflexion Function and Gait Biomechanical Characteristics of Patients With Chronic Plantar Fasciitis
Chronic Plantar Fasciitis, Functional Hallux Limitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanley R Kalish, DPM, FACFAS principal investigator
Atlanta Foot and Leg Clinic
Buck Willis, PhD study director
Dynasplint Systems, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metatarsophalangeal Extension Dynasplint System in people with Hallux Limitus, run by Dynasplint Systems, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Active Range of Motion of Hallux (great toe) Extension (time frame: Two Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00717691, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2012; AzTrials last refreshed its copy on 30 Oct 2026.