Study Stopped
Unrelated to Trial
Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial
Bunionectomy
1 other identifier
interventional
40
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 30, 2012
CompletedFirst Posted
Study publicly available on registry
May 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedAugust 12, 2013
August 1, 2013
4.1 years
April 30, 2012
August 8, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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).
12 months
Study Arms (2)
control/ standard of care
OTHERALL 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
EXPERIMENTALALL 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Diagnosis 1st MTJ Contracture following Bunionectomy
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Brown Hand Center and Achilles Foot & Ankle Specialist
Henderson, Nevada, 89052, United States
Advanced Diagnostic Foot and Ankle Specialist of Cy-Fair
Houston, Texas, 77095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2012
First Posted
May 2, 2012
Study Start
April 1, 2012
Primary Completion
May 1, 2016
Last Updated
August 12, 2013
Record last verified: 2013-08