Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial
This study is currently recruiting participants.
Verified July 2012 by Dynasplint Systems, Inc.
Sponsor:
Dynasplint Systems, Inc.
Collaborator:
McMurry University
Information provided by (Responsible Party):
Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01589679
First received: April 30, 2012
Last updated: July 19, 2012
Last verified: July 2012
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Purpose
To determine the efficacy of Metatarsal Dynasplint Sytem (MTP) in reducing contracture of hallux limitus secondary to Bunionectomy, in a longitudinal, controlled trial.
| Condition | Intervention |
|---|---|
|
Hallux Limitus |
Other: standard of care Device: Metarsal Dynasplint |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial |
Further study details as provided by Dynasplint Systems, Inc.:
Primary Outcome Measures:
- A Repeated Measures Analysis of Variance (ANOVA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]ANOVA will be performed to measure different in category, pain, duration to full restoration of active range of motion(AROM).
| Estimated Enrollment: | 110 |
| Study Start Date: | April 2012 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
control/ standard of care
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.
|
Other: standard of care
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.
|
|
Experimental: Dynasplint
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.
|
Device: Metarsal Dynasplint
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| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589679
Locations
| United States, Florida | |
| Orlando Foot & Ankle Clinic | Recruiting |
| Orlando, Florida, United States, 32822 | |
| Contact: Andres Perez, MD 407-423-1234 | |
| Principal Investigator: Andres Perez | |
| United States, Illinois | |
| Midland Orthopedics Associates | Recruiting |
| Chicago, Illinois, United States, 60616 | |
| Contact: Jennifer Weglarz 312-842-4600 | |
| Principal Investigator: Stephen Perns | |
Sponsors and Collaborators
Dynasplint Systems, Inc.
McMurry University
More Information
No publications provided
| Responsible Party: | Dynasplint Systems, Inc. |
| ClinicalTrials.gov Identifier: | NCT01589679 History of Changes |
| Other Study ID Numbers: | DYN1-12-047 |
| Study First Received: | April 30, 2012 |
| Last Updated: | July 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Contracture Hallux Limitus Hallux Rigidus Joint Diseases |
Musculoskeletal Diseases Muscular Diseases Foot Deformities, Acquired Foot Deformities |
ClinicalTrials.gov processed this record on June 17, 2013