Hallux LimitusBunionectomyNCT01589679
Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial
A study testing Metarsal Dynasplint in people with Hallux Limitus, run by Dynasplint Systems, Inc. at 3 sites in United States.
Trial summary
To determine the efficacy of Metatarsal Dynasplint Sytem (MTP) in reducing contracture of hallux limitus secondary to Bunionectomy, in a longitudinal, controlled trial. 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?
- Metarsal Dynasplint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2012to May 2016
- 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
- Diagnosis 1st MTJ Contracture following Bunionectomy
Who cannot join
- Current treatment with Botulinium Toxin-A (Botox), lower extremity
- Current treatment Fluoroquinolones (antibiotic medication)
- Current use of muscle relaxant medications
- Fibromyalgia
- Stroke, CVA, Brain Injury, Spinal Cord Injury, or any neural pathology causing plasticity or hypertonicity
- Treatment with electrical stimulation assisting ambulation (i.e Bioness, WalkAide, Parastep, etc.)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Brown Hand Center and Achilles Foot & Ankle Specialist
Henderson, Nevada, 89052
Advanced Diagnostic Foot and Ankle Specialist of Cy-Fair
Houston, Texas, 77095
About this study
To determine the efficacy of Metatarsal Dynasplint Sytem (MTP) in reducing contracture of hallux limitus secondary to Bunionectomy, in a longitudinal, controlled trial.
- Conditions
- Hallux Limitus
- Being tested
- standard of care, Metarsal 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.
standard of careOther
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 work for 60 minutes three times per day.
Metarsal DynasplintDevice
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 work for 60 minutes three times per day.
| Study group | Role | What they receive |
|---|---|---|
| control/ standard of care | Other | ALL SUBJECTS WILL RECEIVE SHOE INSERTS AND HOME STRETCHING REGIME. Control subjects will be treated with the Standard of Care during the first 12 weeks, but after the 12 weeks patients will be fit with MTP, which delivers a low-load, prolonged-duration stretch after completion of this study. Receives: Other: standard of care |
| Dynasplint | Experimental | ALL SUBJECTS WILL RECEIVE SHOE INSERTS AND HOME STRETCHING REGIME. Experimental subjects will be immediated treated with the Metatarsal Dynasplint, which delivers a low-load, prolonged-duration stretch for 60 minutes, three times per day. Receives: Device: Metarsal Dynasplint |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Repeated Measures Analysis of Variance (ANOVA)
ANOVA will be performed to measure different in category, pain, duration to full restoration of active range of motion(AROM).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2016 (estimated)
Why it stopped: Unrelated to Trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynasplint Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589679
- Sponsor's protocol ID
- DYN1-12-047
- Acronym
- Bunionectomy
- Status last verified
- Aug 2013
- First submitted
- 30 Apr 2012
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial
- ClinicalTrials.gov ID
- NCT01589679
- Acronym / sponsor ID
- Bunionectomy / DYN1-12-047
- Conditions
- Hallux Limitus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unrelated to Trial
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dynasplint Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- May 2016 (estimated)
- First posted
- 2 May 2012 (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.
To determine the efficacy of Metatarsal Dynasplint Sytem (MTP) in reducing contracture of hallux limitus secondary to Bunionectomy, in a longitudinal, controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control/ standard of care | Other | Other: standard of careALL SUBJECTS WILL RECEIVE SHOE INSERTS AND HOME STRETCHING REGIME. Control subjects will be treated with the Standard of Care during the first 12 weeks, but after the 12 weeks patients will be fit with MTP, which delivers a low-load, prolonged-duration stretch after completion of this study. |
| Dynasplint | Experimental | Device: Metarsal DynasplintALL SUBJECTS WILL RECEIVE SHOE INSERTS AND HOME STRETCHING REGIME. Experimental subjects will be immediated treated with the Metatarsal Dynasplint, which delivers a low-load, prolonged-duration stretch for 60 minutes, three times per day. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis 1st MTJ Contracture following Bunionectomy
Key exclusion criteria (6 listed)
- Current treatment with Botulinium Toxin-A (Botox), lower extremity
- Current treatment Fluoroquinolones (antibiotic medication)
- Current use of muscle relaxant medications
- Fibromyalgia
- Stroke, CVA, Brain Injury, Spinal Cord Injury, or any neural pathology causing plasticity or hypertonicity
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 |
|---|---|---|
| standard of careDynamic 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 work for 60 minutes three times per day. | Other | control/ standard of care |
| Metarsal DynasplintDynamic 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 work for 60 minutes three times per day. | Device | Dynasplint |
Primary outcome
A Repeated Measures Analysis of Variance (ANOVA)
Time frame: 12 months
ANOVA will be performed to measure different in category, pain, duration to full restoration of active range of motion(AROM).
Results and safety
The study was stopped early (reason given: Unrelated to Trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metarsal Dynasplint in people with Hallux Limitus, run by Dynasplint Systems, Inc. at 3 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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early (reason given: Unrelated to Trial). Results are not available in the source record.
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?
A Repeated Measures Analysis of Variance (ANOVA) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2013.