NCT02055495

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
Last Updated

August 8, 2014

Status Verified

August 1, 2014

Enrollment Period

3.9 years

First QC Date

February 3, 2014

Last Update Submit

August 7, 2014

Conditions

Keywords

Painful flatfeetPlanovagus feetSubtalar arthroeresisLateral column lengtheningKinematic motion analysis

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

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

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

Location

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Bruce MacWilliams, Ph.D.

    University of Utah

    PRINCIPAL INVESTIGATOR

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

Locations