FlatfeetNCT02055495
Arthroereisis Versus Lateral Column Lengthening in the Treatment of Planovalgus Feet
An observational study of Flatfeet, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Flatfeet
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Planovalgus foot deformity
- Patient normally ambulates without use of assistive devices
- Patient is between the ages of 7 and 17 at the initial evaluation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children
Salt Lake City, Utah, 84103
About this study
Official title: Prospective Comparison of Subtalar Arthroereisis To Lateral Column Lengthening for Painful Flatfeet
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.
Read the 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.
- Conditions
- Flatfeet
- Keywords
- Painful flatfeet, Planovagus feet, Subtalar arthroeresis, Lateral column lengthening, Kinematic motion analysis
- Medical subject headings
- Flatfoot
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startMar 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlatfeetStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce MacWilliams, University of Utah
- Investigators
- Bruce MacWilliams, Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055495
- Sponsor's protocol ID
- 40286
- Status last verified
- Aug 2014
- First submitted
- 3 Feb 2014
- Last updated
- 8 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Subtalar Arthroereisis To Lateral Column Lengthening for Painful Flatfeet
- ClinicalTrials.gov ID
- NCT02055495
- Acronym / sponsor ID
- 40286
- Conditions
- Flatfeet
- Keywords
- Painful flatfeet, Planovagus feet, Subtalar arthroeresis, Lateral column lengthening, Kinematic motion analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 5 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Planovalgus foot deformity
- Patient normally ambulates without use of assistive devices
- Patient is between the ages of 7 and 17 at the initial evaluation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce MacWilliams, Ph.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Flatfeet, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematics motion analysis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2014.