Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial

Not Applicable

Terminated

• Conditions: Hallux Limitus

• Registration Number: NCT01589679
• Lead Sponsor: Dynasplint Systems, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-04-30
• Study First Posted: 2012-05-02
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-08
• Last Update Posted: 2013-08-12
• Primary Completion: 2016-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
A Repeated Measures Analysis of Variance (ANOVA)	12 months	ANOVA will be performed to measure different in category, pain, duration to full restoration of active range of motion(AROM).

Trial Locations

Locations (3)

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, United States