Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial

Dynasplint Systems.

Status: Terminated

Conditions: Hallux Limitus

Treatments: Device: Metarsal Dynasplint; Other: standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01589679

DYN1-12-047

Details and patient eligibility

About

To determine the efficacy of Metatarsal Dynasplint Sytem (MTP) in reducing contracture of hallux limitus secondary to Bunionectomy, in a longitudinal, controlled trial.

Enrollment: 40 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

control/ standard of care

Other group

Description:

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.

Treatment:

Other: standard of care

Dynasplint

Experimental group

Description:

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.

Treatment:

Device: Metarsal Dynasplint