Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial

Dynasplint Systems.

Status: Completed

Conditions: Hallux Limitus

Treatments: Device: Metatarsophalangeal Extension Dynasplint System; Other: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT00717691

2008.003

Details and patient eligibility

About

The purpose of this study is to regain range of motion of the great toe with dynamic splinting which will help reduce great toe's pain and swelling.

Full description

Determine the efficacy of dynamic splinting in treating patients with hallux limitus, in a randomized, controlled trial.

Enrollment: 50 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Reduced flexibility in AROM of extension in the great toe
• Pain that is worsened by walking and/or squatting
• Impaired gait pattern

Exclusion criteria

• Metatarsal stress fracture
• Interdigital neuroma
• Sesamoid pathology
• Gout
• Metatarsalgia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Experimental group

Description:

Immediate fitting with dynamic splinting following diagnosis of hallux limitus.

Treatment:

Device: Metatarsophalangeal Extension Dynasplint System

Other: Standard of Care

2

No Intervention group

Description:

Control arm; patients only treated with standard of care following diagnosis of hallux limitus.

Treatment:

Other: Standard of Care