- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02055495
Arthroereisis Versus Lateral Column Lengthening in the Treatment of Planovalgus Feet
Prospective Comparison of Subtalar Arthroereisis To Lateral Column Lengthening for Painful Flatfeet
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Utah
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Salt Lake City, Utah, United States, 84103
- Shriners Hospitals for Children
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Kinematics motion analysis
Time Frame: 1 year
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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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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bruce MacWilliams, Ph.D., University of Utah
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 40286
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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