Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial

This study has been terminated.
(Unrelated to Trial)
Sponsor:
Information provided by (Responsible Party):
Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01589679
First received: April 30, 2012
Last updated: August 8, 2013
Last verified: August 2013
  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).


Enrollment: 40
Study Start Date: April 2012
Estimated Primary Completion Date: May 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589679

Locations
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Nevada
Brown Hand Center and Achilles Foot & Ankle Specialist
Henderson, Nevada, United States, 89052
United States, Texas
Advanced Diagnostic Foot and Ankle Specialist of Cy-Fair
Houston, Texas, United States, 77095
Sponsors and Collaborators
Dynasplint Systems, Inc.
  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: August 8, 2013
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 August 28, 2014