Arthroereisis Versus Lateral Column Lengthening in the Treatment of Planovalgus Feet

NCT ID: NCT02055495

Last Updated: 2014-08-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-02-28

Brief Summary

There is no consensus on the surgical treatment of unremitting, painful flatfeet in children. Subtalar arthroereisis has gained notoriety although there is a paucity of literature on its biomechanical effects. The goal of the investigators was to compare a group treated with subtalar arthroereisis with another group undergoing lateral column calcaneal lengthening. The investigators hypothesis was that the results of arthroereisis would be equivalent to the more established method of calcaneal lengthening.

Detailed Description

The purpose of this prospective, non-randomized study was to evaluate two different surgical treatments for symptomatic planovalgus feet: lateral column lengthening osteotomy and subtalar arthroereisis. The goal of the investigators was to compare the outcomes of these two surgeries and determine whether both treatments resulted in clinical improvement. This was accomplished through the use of pre- and post-operative kinematics, pedobarography, radiographic measurements, and validated outcome measures. The investigators were particularly interested in analyzing the kinematic changes to quantify the changes in the foot mobility and alignment during ambulation, as it has not been previously studied to our knowledge. The investigators hypothesis was that both procedures would show significant improvement and be equivalent in their results.

A prospective trial was conducted. The investigators enrolled fifteen patients (mean age 12.8y, 24 feet) with painful, planovalgus feet refractory to conservative treatment. Seven patients (13 feet) were enrolled in the arthroereisis group, and eight patients (11 feet) were enrolled in the calcaneal lengthening group. Though not specifically excluded, none of the enrolled patients had an underlying neuromuscular diagnosis. Kinematic motion analysis was performed on each patient prior to surgery and at one year of follow-up. Pedobarometry studies, radiographs, and validated outcome questionnaires (Oxford Ankle-Foot Questionnaire for Children) were also performed to evaluate the outcomes of both groups.

Conditions

Flatfeet

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Planovalgus foot deformity
• Patient normally ambulates without use of assistive devices
• Patient is between the ages of 7 and 17 at the initial evaluation

Exclusion Criteria

• Hip flexion contractures greater than 15 deg.
• Knee flexion contractures greater than 10 deg.
• Ankle dorsiflexion less than 0 deg. (plantarflexion contracture)
• Taking medication which effects motor control
• Inability to follow instructions to perform study

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Bruce MacWilliams

Associate Professor, Director, Movement Analysis Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce MacWilliams, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Shriners Hospitals for Children

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

40286

Identifier Type: -

Identifier Source: org_study_id