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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:
NCT00717691
First received: July 15, 2008
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Hallux Limitus
Device: Metatarsophalangeal Extension Dynasplint System
Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial

Further study details as provided by Dynasplint Systems, Inc.:

Primary Outcome Measures:
  • Change in Active Range of Motion of Hallux (great toe) Extension [ Time Frame: Two Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in passive Range of Motion, Extension [ Time Frame: same ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2008
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Immediate fitting with dynamic splinting following diagnosis of hallux limitus.
Device: Metatarsophalangeal Extension Dynasplint System
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 worn for 30 minutes, three times per day, (while seated or resting in bed) totaling 1.5 hours per day.
Other: Standard of Care
The current standard of care in treating Hallux Limitus will be given to all patients regardless of randomized categorization, and this includes: analgesic and nonsteroidal anti-inflammatory drugs (NSAIDs), orthotics with medial stiffness, and reduction of great toe movement in motions such as kneeling or squatting with the toes in an extended position.
No Intervention: 2
Control arm; patients only treated with standard of care following diagnosis of hallux limitus.
Other: Standard of Care
The current standard of care in treating Hallux Limitus will be given to all patients regardless of randomized categorization, and this includes: analgesic and nonsteroidal anti-inflammatory drugs (NSAIDs), orthotics with medial stiffness, and reduction of great toe movement in motions such as kneeling or squatting with the toes in an extended position.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717691

Locations
United States, Georgia
Atlanta Foot and Leg Clinic
Jonesboro, Georgia, United States, 30236
Ankle and Foot Centers, PC
Marietta, Georgia, United States, 30066
Sponsors and Collaborators
Dynasplint Systems, Inc.
Investigators
Principal Investigator: Stanley R Kalish, DPM, FACFAS Atlanta Foot and Leg Clinic
Study Director: Buck Willis, PhD Dynasplint Systems, Inc.
  More Information

Publications:
Willis B, John M. Dynamic Splinting Increases Flexion for Hallux Rigidus (Pilot Study). BioMechanics, 2007 Sept;14(9), pg49-53
Becher C, Kilger R, Thermann H. Results of cheilectomy and additional microfracture techniques for the treatment of hallux rigidus. Foot Ankle Surg. 2005;(10): 155-160
Willis B. Dancers restore knee flexion through dynamic splinting. BioMechanics. 2008;Jan;15(1), pg49-54

Responsible Party: Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier: NCT00717691     History of Changes
Other Study ID Numbers: 2008.003
Study First Received: July 15, 2008
Last Updated: April 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dynasplint Systems, Inc.:
Hallux Limitus
Dynamic Splinting
Dynasplint

Additional relevant MeSH terms:
Hallux Limitus
Hallux Rigidus
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Joint Diseases

ClinicalTrials.gov processed this record on October 01, 2014