Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial

Hallux Limitus Clinical Trial

— Bunionectomy  

Official title:

Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01589679
• Other study ID #: DYN1-12-047
• Status: Terminated
• Phase: N/A
• First received: April 30, 2012
• Last updated: August 8, 2013
• Start date: April 2012

Study information

• Verified date: August 2013
• Source: Dynasplint Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contracture
• Hallux Limitus
• Hallux Rigidus

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	Brown Hand Center and Achilles Foot & Ankle Specialist	Henderson	Nevada
United States	Advanced Diagnostic Foot and Ankle Specialist of Cy-Fair	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Dynasplint Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No