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Arthroereisis Versus Lateral Column Lengthening in the Treatment of Planovalgus Feet

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ClinicalTrials.gov Identifier: NCT02055495
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Bruce MacWilliams, University of Utah

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.

Condition or disease
Flatfeet

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.

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Comparison of Subtalar Arthroereisis To Lateral Column Lengthening for Painful Flatfeet
Study Start Date : March 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014



Primary Outcome Measures :
  1. Kinematics motion analysis [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient ages ranged from 7 to 17 (mean 12.8y) at the time of surgery. Inclusion criteria were patients with planovalgus deformity, painful symptoms refractory to conservative treatment for at least 6 months, and independent ambulation without the use of assistive devices.

A longitudinally study of two patient cohorts: 1) children with planovalgus foot deformity treated with arthroereisis (subtalar implant) and 2) children with planovalgus foot deformity treated by calcaneal (lateral column) lengthening.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055495


Locations
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United States, Utah
Shriners Hospitals for Children
Salt Lake City, Utah, United States, 84103
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Bruce MacWilliams, Ph.D. University of Utah

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Responsible Party: Bruce MacWilliams, Associate Professor, Director, Movement Analysis Laboratory, University of Utah
ClinicalTrials.gov Identifier: NCT02055495    
Other Study ID Numbers: 40286
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014
Keywords provided by Bruce MacWilliams, University of Utah:
Painful flatfeet
Planovagus feet
Subtalar arthroeresis
Lateral column lengthening
Kinematic motion analysis
Additional relevant MeSH terms:
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Flatfoot
Talipes
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities