Back to resultsContracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial (Bunionectomy)
Primary Purpose
Hallux Limitus
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standard of care
Metarsal Dynasplint
Sponsored by
About this trial
This is an interventional treatment trial for Hallux Limitus
Eligibility Criteria
Inclusion Criteria:
- Diagnosis 1st MTJ Contracture following Bunionectomy
Exclusion Criteria:
- 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.)
Sites / Locations
- Tufts Medical Center
- Brown Hand Center and Achilles Foot & Ankle Specialist
- Advanced Diagnostic Foot and Ankle Specialist of Cy-Fair
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
control/ standard of care
Dynasplint
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01589679
First Posted
April 30, 2012
Last Updated
August 8, 2013
Sponsor
Dynasplint Systems, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01589679
Brief Title
Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial
Acronym
Bunionectomy
Official Title
Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Unrelated to Trial
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynasplint Systems, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the efficacy of Metatarsal Dynasplint Sytem (MTP) in reducing contracture of hallux limitus secondary to Bunionectomy, in a longitudinal, controlled trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Limitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control/ standard of care
Arm Type
Other
Arm Description
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.
Arm Title
Dynasplint
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
standard of care
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 work for 60 minutes three times per day.
Intervention Type
Device
Intervention Name(s)
Metarsal Dynasplint
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 work for 60 minutes three times per day.
Primary Outcome Measure Information:
Title
A Repeated Measures Analysis of Variance (ANOVA)
Description
ANOVA will be performed to measure different in category, pain, duration to full restoration of active range of motion(AROM).
Time Frame
12 months
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:
Diagnosis 1st MTJ Contracture following Bunionectomy
Exclusion Criteria:
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.)
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Brown Hand Center and Achilles Foot & Ankle Specialist
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Advanced Diagnostic Foot and Ankle Specialist of Cy-Fair
City
Houston
State/Province
Texas
ZIP/Postal Code
77095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial
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