Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01589679

Acronym

Bunionectomy

Enrollment

Registered

2012-05-02

Start date

2012-04-30

Completion date

Unknown

Last updated

2013-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Limitus

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.

Interventions

OTHERstandard 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.

DEVICEMetarsal Dynasplint

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.)

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026