ClubfootNCT03953430
Gait Analysis in Children With Clubfoot Treated With Tibialis Anterior Tendon Transfer
An observational study of Clubfoot, run by Orthopedic Hospital Vienna Speising.
Trial summary
Patients with clubfoot treated with the Ponseti method and undergoing Tibialis Anterior tendon transfer from a prospective database are evaluated using gait analysis including the Oxford foot model and compared to a group of healthy children. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Clubfoot
- What is being tested?
- Gait analysis
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 30 Mar 2018
- 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 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients with dynamic clubfoot recurrence with a minimum age of three years from a prospective, consecutive database of patients with clubfoot treated with the Ponseti method
Who may be able to join
- Children with unilateral or bilateral idiopathic clubfoot treated with the Ponseti method
- full TATT
Who cannot join
- clubfoot associated with syndromes or neurological diseases
- initial Treatment elsewhere with more than 3 casts
- prior joint invasive or bony surgery
- split transfer of the tibialis anterior tendon
About this study
Official title: Normalization of Forefoot Supination After Tibialis Anterior Tendon Transfer for Dynamic Clubfoot Recurrence
Patients with clubfoot treated with the Ponseti method and undergoing Tibialis Anterior tendon transfer from a prospective database are evaluated using gait analysis including the Oxford foot model and compared to a group of healthy children.
Read the detailed description
Children with dynamic clubfoot recurrence after initial Ponseti treatment who underwent TATT between 2014 and 2017 are considered for this study. Exclusion criteria are neurological disease, split transfer of the tendon, additional bone or joint invasive surgery, and initial treatment abroad.
Gait analysis, including the Oxford foot model, will be conducted, and the kinematic and kinetic data of the lower extremity will be compared with a group of age-matched healthy children. To comprise a control group for the purpose of collecting gait analysis data of healthy children, employees of our hospital are asked to allow their children to participate in this study.
Patients will undergo gait analysis, including video recordings with a Vicon motion capture system (Vicon, Oxford, UK) with kinetic data collected from three AMTI force plates (Advanced Mechanical Technology, Inc., Watertown, MA). Placement of markers will be a combination of Cleveland (lower extremity), PlugInGait (upper body), and Oxford Foot (movement within the foot) models.
- Conditions
- Clubfoot
- Being tested
- Gait analysis
- Keywords
- Tibialis anterior tendon transfer, Oxford foot model, gait analysis
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysisOther
| Study group | Role | What they receive |
|---|---|---|
| study group | Patients with clubfoot recurrence undergoing Tibialis Anterior tendon transfer with a minimum age of three years from a prospective, consecutive database of patients with clubfoot treated with the Ponseti method. Receives: Other: Gait analysis | |
| control group | healthy children of employees of our hospital Receives: Other: Gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in forefoot supination in relation to hindfoot after TATT during swing
The primary outcome measure is forefoot supination in relation to the hindfoot during swing. Changes of forefoot supination during swing after TATT (6-12 months postoperatively) are compared to preoperative values (Oxford foot model). The parameter is a mean value (in degree) of swing phase supination.
Therefore gait analysis, including video recordings with a Vicon motion capture system (Vicon, Oxford, UK) with kinetic data collected from three AMTI force plates (Advanced Mechanical Technology, Inc., Watertown, MA) will be conducted. Placement of markers will be a combination of Cleveland (lower extremity), PlugInGait (upper body), and Oxford Foot (movement within the foot) models.
Analysis will include graphic gait curve analysis as well as statistical analysis of pre- to postoperative changes.
Measured: preoperative (1-21 days) and 6-12 months postoperatively
Changes in forefoot adduction in relation to hindfoot after TATT during swing
Another primary outcome measure is forefoot adduction in relation to the hindfoot during swing. Changes of forefoot adduction during swing after TATT (6-12 months postoperatively) are compared to preoperative values (Oxford foot model). The parameter is a mean value (in degree) of swing phase adduction.
Therefore gait analysis, including video recordings with a Vicon motion capture system (Vicon, Oxford, UK) with kinetic data collected from three AMTI force plates (Advanced Mechanical Technology, Inc., Watertown, MA) will be conducted. Placement of markers will be a combination of Cleveland (lower extremity), PlugInGait (upper body), and Oxford Foot (movement within the foot) models.
Analysis will include graphic gait curve analysis as well as statistical analysis of pre- to postoperative changes.
Measured: preoperative (1-21 days) and 6-12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start1 Jan 2014
- Primary completion1 Jan 2017
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ClubfootStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopedic Hospital Vienna Speising
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christof Radler, Orthopedic Hospital Vienna Speising
- Investigators
- Christof Radler, MD, Study director, Orthopedic Hospital Vienna Speising
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953430
- Sponsor's protocol ID
- TATT
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mindler GT, Kranzl A, Lipkowski CA, Ganger R, Radler C. Results of gait analysis including the Oxford foot model in children with clubfoot treated with the Ponseti method. J Bone Joint Surg Am. 2014 Oct 1;96(19):1593-9. doi: 10.2106/JBJS.M.01603.
PubMed 25274784
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normalization of Forefoot Supination After Tibialis Anterior Tendon Transfer for Dynamic Clubfoot Recurrence
- ClinicalTrials.gov ID
- NCT03953430
- Acronym / sponsor ID
- TATT
- Conditions
- Clubfoot
- Keywords
- Tibialis anterior tendon transfer, Oxford foot model, gait analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Orthopedic Hospital Vienna SpeisingUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 16 May 2019 (actual)
- 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.
Patients with clubfoot treated with the Ponseti method and undergoing Tibialis Anterior tendon transfer from a prospective database are evaluated using gait analysis including the Oxford foot model and compared to a group of healthy children.
Detailed description
Children with dynamic clubfoot recurrence after initial Ponseti treatment who underwent TATT between 2014 and 2017 are considered for this study. Exclusion criteria are neurological disease, split transfer of the tendon, additional bone or joint invasive surgery, and initial treatment abroad.
Gait analysis, including the Oxford foot model, will be conducted, and the kinematic and kinetic data of the lower extremity will be compared with a group of age-matched healthy children. To comprise a control group for the purpose of collecting gait analysis data of healthy children, employees of our hospital are asked to allow their children to participate in this study.
Patients will undergo gait analysis, including video recordings with a Vicon motion capture system (Vicon, Oxford, UK) with kinetic data collected from three AMTI force plates (Advanced Mechanical Technology, Inc., Watertown, MA). Placement of markers will be a combination of Cleveland (lower extremity), PlugInGait (upper body), and Oxford Foot (movement within the foot) models.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: Gait analysisPatients with clubfoot recurrence undergoing Tibialis Anterior tendon transfer with a minimum age of three years from a prospective, consecutive database of patients with clubfoot treated with the Ponseti method. |
| control group | – | Other: Gait analysishealthy children of employees of our hospital |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients with dynamic clubfoot recurrence with a minimum age of three years from a prospective, consecutive database of patients with clubfoot treated with the Ponseti method
Key inclusion criteria (2 listed)
- Children with unilateral or bilateral idiopathic clubfoot treated with the Ponseti method
- full TATT
Key exclusion criteria (4 listed)
- clubfoot associated with syndromes or neurological diseases
- initial Treatment elsewhere with more than 3 casts
- prior joint invasive or bony surgery
- split transfer of the tibialis anterior tendon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait analysis | Other | control group, study group |
Primary outcome
Changes in forefoot supination in relation to hindfoot after TATT during swing
Time frame: preoperative (1-21 days) and 6-12 months postoperatively
The primary outcome measure is forefoot supination in relation to the hindfoot during swing. Changes of forefoot supination during swing after TATT (6-12 months postoperatively) are compared to preoperative values (Oxford foot model). The parameter is a mean value (in degree) of swing phase supination. Therefore gait analysis, including video recordings with a Vicon motion capture system (Vicon, Oxford, UK) with kinetic data collected from three AMTI force plates (Advanced Mechanical Technology, Inc., Watertown, MA) will be conducted. Placement of markers will be a combination of Cleveland (lower extremity), PlugInGait (upper body), and Oxford Foot (movement within the foot) models. Analysis will include graphic gait curve analysis as well as statistical analysis of pre- to postoperative changes.
Changes in forefoot adduction in relation to hindfoot after TATT during swing
Time frame: preoperative (1-21 days) and 6-12 months postoperatively
Another primary outcome measure is forefoot adduction in relation to the hindfoot during swing. Changes of forefoot adduction during swing after TATT (6-12 months postoperatively) are compared to preoperative values (Oxford foot model). The parameter is a mean value (in degree) of swing phase adduction. Therefore gait analysis, including video recordings with a Vicon motion capture system (Vicon, Oxford, UK) with kinetic data collected from three AMTI force plates (Advanced Mechanical Technology, Inc., Watertown, MA) will be conducted. Placement of markers will be a combination of Cleveland (lower extremity), PlugInGait (upper body), and Oxford Foot (movement within the foot) models. Analysis will include graphic gait curve analysis as well as statistical analysis of pre- to postoperative changes.
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 16 May 2019.
- Background: PubMed 25274784Mindler GT, Kranzl A, Lipkowski CA, Ganger R, Radler C. Results of gait analysis including the Oxford foot model in children with clubfoot treated with the Ponseti method. J Bone Joint Surg Am. 2014 Oct 1;96(19):1593-9. doi: 10.2106/JBJS.M.01603.
Related trials for Clubfoot
Recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
Pes Planus
Not yet recruiting
Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
Not yet recruiting
The Corrective Power of Subtalar Arthrodesis With Mini/Medial Bone Block (SAMBB) in Patients Affected by Progressive Collapsing Foot Deformity (PCFD): Analysis Using Weight-bearing Cone Beam CT.
Flat Foot
Not yet recruitingObservational study
Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects
Flexible Flatfoot
Recruiting
Plantar Stimulation, Whole-Body Vibration, and Baduanjin for Muscle Activation
Flat Feet, Lower-Limb Muscle Activation
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.
Christof Radler, MD study director
Orthopedic Hospital Vienna Speising
Questions about this trial
What is this clinical trial studying?
An observational study of Clubfoot, run by Orthopedic Hospital Vienna Speising.
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 2 inclusion and 4 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 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in forefoot supination in relation to hindfoot after TATT during swing (time frame: preoperative (1-21 days) and 6-12 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03953430, which also lists 1 linked publication.
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 16 May 2019.