Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial

Not Applicable

Terminated

• Conditions: Hallux Limitus
• Interventions: Other: standard of care; Device: Metarsal Dynasplint

• 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

Arm && Interventions

Group	Intervention	Description
control/ standard of care	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.
Dynasplint	Metarsal 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.

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)

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

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States