Arthroereisis Versus Lateral Column Lengthening in the Treatment of Planovalgus Feet

Flatfeet Clinical Trial

Official title:

Prospective Comparison of Subtalar Arthroereisis To Lateral Column Lengthening for Painful Flatfeet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055495
• Other study ID #: 40286
• Status: Completed
• Phase: N/A
• First received: February 3, 2014
• Last updated: August 7, 2014
• Start date: March 2010
• Est. completion date: February 2014

Study information

• Verified date: August 2014
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Flatfeet
• Flatfoot

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinematics motion analysis	The change in hindfoot angle, degree of hindfoot mobility both pre- and postoperatively, degree of ankle motion both pre- and postoperatively, and amount of flexion occurring between the forefoot and hindfoot both pre- and postoperatively.	1 year	No