Arthroereisis Versus Lateral Column Lengthening in the Treatment of Planovalgus Feet
Prospective Comparison of Subtalar Arthroereisis To Lateral Column Lengthening for Painful Flatfeet
1 other identifier
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 3, 2014
CompletedFirst Posted
Study publicly available on registry
February 5, 2014
CompletedAugust 8, 2014
August 1, 2014
3.9 years
February 3, 2014
August 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
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.
You may qualify if:
- Planovalgus foot deformity
- Patient normally ambulates without use of assistive devices
- Patient is between the ages of 7 and 17 at the initial evaluation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shriners Hospitals for Children
Salt Lake City, Utah, 84103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce MacWilliams, Ph.D.
University of Utah
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Director, Movement Analysis Laboratory
Study Record Dates
First Submitted
February 3, 2014
First Posted
February 5, 2014
Study Start
March 1, 2010
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
August 8, 2014
Record last verified: 2014-08