Pediatric Flexible FlatfootSTA-PFFNCT07803341
Clinical and Functional Outcomes After Subtalar Arthroereisis in Pediatric Flexible Flatfoot
An observational study of Pediatric Flexible Flatfoot, run by University of Pavia at 1 site in Italy.
Trial summary
Flexible flatfoot is common in children and adolescents. In some patients, the condition remains painful or limits activity despite non-surgical treatment. Subtalar arthroereisis is a minimally invasive operation in which an implant is placed in the sinus tarsi to limit excessive foot pronation while preserving joint… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Flexible Flatfoot
- What is being tested?
- Subtalar Arthroereisis
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 13 Apr 2026to 31 Jan 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pediatric patients aged 10 to 18 years with symptomatic flexible flatfoot referred to the participating orthopedic unit and scheduled for elective subtalar arthroereisis after failure of appropriate conservative management or because of persistent symptoms, progressive deformity, or substantial functional impairment.
Who may be able to join
- Scheduled for elective subtalar arthroereisis, with or without adjunctive surgical procedures.
- Aged 10 to 18 years at the time of enrollment.
- Male or female.
Who cannot join
- Concomitant orthopedic or neurological conditions affecting walking ability.
- Neurological or vestibular disorders affecting balance.
- Contraindications to the medical devices used in the study.
- Inability to understand and sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Baropodometric Evaluation After Subtalar Arthroereisis for Pediatric Flexible Flatfoot: An Observational Cohort Study
Flexible flatfoot is common in children and adolescents. In some patients, the condition remains painful or limits activity despite non-surgical treatment. Subtalar arthroereisis is a minimally invasive operation in which an implant is placed in the sinus tarsi to limit excessive foot pronation while preserving joint movement.
This observational study follows children and adolescents who receive subtalar arthroereisis as part of their planned clinical care. Clinical status, standing foot radiographs, plantar-pressure distribution, and walking characteristics are assessed before surgery and six months after surgery. The study aims primarily to describe changes in dynamic plantar loading and walking parameters. Changes in clinical scores and radiographic alignment are assessed as secondary outcomes. No treatment is assigned for research purposes, and all surgical and postoperative decisions are made according to routine clinical indications.
- Conditions
- Pediatric Flexible Flatfoot
- Being tested
- Subtalar Arthroereisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtalar ArthroereisisProcedure or surgery
A conical titanium implant is inserted into the sinus tarsi through a minimally invasive approach to restrict excessive subtalar pronation while preserving joint mobility. Implant size and position are assessed clinically and under fluoroscopic guidance. Additional soft-tissue or navicular procedures may be performed when clinically indicated, including gastrocnemius lengthening; excision or regularization of a symptomatic accessory or prominent navicular; posterior tibial tendon reinsertion or retensioning; or anterior tibial tendon tenosuspension according to the Young technique. These procedures are determined by clinical need and are not assigned by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Children and adolescents aged 10 to 18 years with symptomatic flexible flatfoot. | Children and adolescents aged 10 to 18 years with symptomatic flexible flatfoot and a clinical indication for elective subtalar arthroereisis. Participants receive the operation as part of routine clinical care and undergo clinical, radiographic, and dynamic baropodometric assessment before surgery and at six months after surgery. Receives: Procedure: Subtalar Arthroereisis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step-Cycle Duration
Measured: Baseline and 6 months after surgery
Ground-Contact Duration
Measured: Baseline and 6 months after surgery
Double-Support Duration
Measured: Baseline and 6 months after surgery
Step Length
Measured: Baseline and 6 months after surgery
Anteroposterior Talonavicular Coverage Angle Measured on Weight-Bearing Radiographs Using Synapse
The anteroposterior talonavicular coverage angle will be measured in degrees using the Synapse software on radiographic images. The measurement will be performed at baseline, before surgery (T0), and approximately 6 months after surgery (T1), in the operated foot. The change from baseline to 6 months after surgery will be evaluated.
Measured: Baseline and 6 months after surgery
Anteroposterior Talocalcaneal Angle Measured Using Synapse
The anteroposterior talocalcaneal angle will be measured in degrees using the Synapse software on radiographic images. The measurement will be performed at baseline, before surgery (T0), and approximately 6 months after surgery (T1), in the operated foot. The change from baseline to 6 months after surgery will be evaluated.
Measured: Baseline and 6 months after surgery
Lateral Meary's Angle Measured Using Synapse
The lateral Meary's angle will be measured in degrees using the Synapse software on radiographic images. The measurement will be performed at baseline, before surgery (T0), and approximately 6 months after surgery (T1), in the operated foot. The change from baseline to 6 months after surgery will be evaluated.
Measured: Baseline and 6 months after surgery
Lateral Calcaneal Pitch Measured Using Synapse
The lateral calcaneal pitch will be measured in degrees using the Synapse software on radiographic images. The measurement will be performed at baseline, before surgery (T0), and approximately 6 months after surgery (T1), in the operated foot. The change from baseline to 6 months after surgery will be evaluated.
Measured: Baseline and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start13 Apr 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pediatric Flexible FlatfootStudies 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
- Prospective
- Enrolment
- 25 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Marin, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803341
- Sponsor's protocol ID
- 0035422/26
- Acronym
- STA-PFF
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Publications
Brancheau SP, Walker KM, Northcutt DR. An analysis of outcomes after use of the Maxwell-Brancheau Arthroereisis implant. J Foot Ankle Surg. 2012 Jan-Feb;51(1):3-8. doi: 10.1053/j.jfas.2011.10.019.
PubMed 22196453Indino C, Villafane JH, D'Ambrosi R, Manzi L, Maccario C, Berjano P, Usuelli FG. Effectiveness of subtalar arthroereisis with endorthesis for pediatric flexible flat foot: a retrospective cross-sectional study with final follow up at skeletal maturity. Foot Ankle Surg. 2020 Jan;26(1):98-104. doi: 10.1016/j.fas.2018.12.002. Epub 2018 Dec 21.
PubMed 30598422Leigheb M, Janicka P, Andorno S, Marcuzzi A, Magnani C, Grassi F. Italian translation, cultural adaptation and validation of the "American Orthopaedic Foot and Ankle Society's (AOFAS) ankle-hindfoot scale". Acta Biomed. 2016 May 6;87(1):38-45.
PubMed 27163894Atik A, Ozyurek S. Flexible flatfoot. North Clin Istanb. 2014 Aug 3;1(1):57-64. doi: 10.14744/nci.2014.29292. eCollection 2014.
PubMed 28058304Longo UG, Papalia R, De Salvatore S, Ruzzini L, Candela V, Piergentili I, Oggiano L, Costici PF, Denaro V. Trends in hospitalization for paediatric flatfoot: an Italian nationwide study from 2001 to 2016. BMC Pediatr. 2022 Feb 8;22(1):83. doi: 10.1186/s12887-022-03145-0.
PubMed 35135510Mosca VS. Flexible flatfoot in children and adolescents. J Child Orthop. 2010 Apr;4(2):107-21. doi: 10.1007/s11832-010-0239-9. Epub 2010 Feb 18.
PubMed 21455468Fan Y, Fan Y, Li Z, Lv C, Luo D. Natural gaits of the non-pathological flat foot and high-arched foot. PLoS One. 2011 Mar 18;6(3):e17749. doi: 10.1371/journal.pone.0017749.
PubMed 21445254Shin HS, Lee JH, Kim EJ, Kyung MG, Yoo HJ, Lee DY. Flatfoot deformity affected the kinematics of the foot and ankle in proportion to the severity of deformity. Gait Posture. 2019 Jul;72:123-128. doi: 10.1016/j.gaitpost.2019.06.002. Epub 2019 Jun 5.
PubMed 31195311Ryu SM, Lee TK, Lee SH. Prevalence of flatfoot among young Korean males and the correlation among flatfoot angles measured in weight-bearing lateral radiographs. Medicine (Baltimore). 2022 Jul 29;101(30):e29720. doi: 10.1097/MD.0000000000029720.
PubMed 35905246Chen C, Jiang J, Fu S, Wang C, Su Y, Mei G, Xue J, Zou J, Li X, Shi Z. HyProCure for Pediatric Flexible Flatfoot: What Affects the Outcome. Front Pediatr. 2022 Apr 14;10:857458. doi: 10.3389/fped.2022.857458. eCollection 2022.
PubMed 35498774Wang S, Chen L, Yu J, Zhang C, Huang JZ, Wang X, Ma X. Mid-term Results of Subtalar Arthroereisis with Talar-Fit Implant in Pediatric Flexible Flatfoot and Identifying the Effects of Adjunctive Procedures and Risk Factors for Sinus Tarsi Pain. Orthop Surg. 2021 Feb;13(1):175-184. doi: 10.1111/os.12864. Epub 2020 Dec 17.
PubMed 33332772
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baropodometric Evaluation After Subtalar Arthroereisis for Pediatric Flexible Flatfoot: An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07803341
- Acronym / sponsor ID
- STA-PFF / 0035422/26
- Conditions
- Pediatric Flexible Flatfoot
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 3 Sep 2026 (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.
Flexible flatfoot is common in children and adolescents. In some patients, the condition remains painful or limits activity despite non-surgical treatment. Subtalar arthroereisis is a minimally invasive operation in which an implant is placed in the sinus tarsi to limit excessive foot pronation while preserving joint movement.
This observational study follows children and adolescents who receive subtalar arthroereisis as part of their planned clinical care. Clinical status, standing foot radiographs, plantar-pressure distribution, and walking characteristics are assessed before surgery and six months after surgery. The study aims primarily to describe changes in dynamic plantar loading and walking parameters. Changes in clinical scores and radiographic alignment are assessed as secondary outcomes. No treatment is assigned for research purposes, and all surgical and postoperative decisions are made according to routine clinical indications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and adolescents aged 10 to 18 years with symptomatic flexible flatfoot. | – | Procedure: Subtalar ArthroereisisChildren and adolescents aged 10 to 18 years with symptomatic flexible flatfoot and a clinical indication for elective subtalar arthroereisis. Participants receive the operation as part of routine clinical care and undergo clinical, radiographic, and dynamic baropodometric assessment before surgery and at six months after surgery. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients aged 10 to 18 years with symptomatic flexible flatfoot referred to the participating orthopedic unit and scheduled for elective subtalar arthroereisis after failure of appropriate conservative management or because of persistent symptoms, progressive deformity, or substantial functional impairment.
Key inclusion criteria (3 listed)
- Scheduled for elective subtalar arthroereisis, with or without adjunctive surgical procedures.
- Aged 10 to 18 years at the time of enrollment.
- Male or female.
Key exclusion criteria (4 listed)
- Concomitant orthopedic or neurological conditions affecting walking ability.
- Neurological or vestibular disorders affecting balance.
- Contraindications to the medical devices used in the study.
- Inability to understand and sign the informed consent form.
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 |
|---|---|---|
| Subtalar ArthroereisisA conical titanium implant is inserted into the sinus tarsi through a minimally invasive approach to restrict excessive subtalar pronation while preserving joint mobility. Implant size and position are assessed clinically and under fluoroscopic guidance. Additional soft-tissue or navicular procedures may be performed when clinically indicated, including gastrocnemius lengthening; excision or regularization of a symptomatic accessory or prominent navicular; posterior tibial tendon reinsertion or retensioning; or anterior tibial tendon tenosuspension according to the Young technique. These procedures are determined by clinical need and are not assigned by the study protocol. | Procedure or surgery | Children and adolescents aged 10 to 18 years with symptomatic flexible flatfoot. |
Primary outcome
Step-Cycle Duration
Time frame: Baseline and 6 months after surgery
Ground-Contact Duration
Time frame: Baseline and 6 months after surgery
Double-Support Duration
Time frame: Baseline and 6 months after surgery
Step Length
Time frame: Baseline and 6 months after surgery
Anteroposterior Talonavicular Coverage Angle Measured on Weight-Bearing Radiographs Using Synapse
Time frame: Baseline and 6 months after surgery
The anteroposterior talonavicular coverage angle will be measured in degrees using the Synapse software on radiographic images. The measurement will be performed at baseline, before surgery (T0), and approximately 6 months after surgery (T1), in the operated foot. The change from baseline to 6 months after surgery will be evaluated.
Anteroposterior Talocalcaneal Angle Measured Using Synapse
Time frame: Baseline and 6 months after surgery
The anteroposterior talocalcaneal angle will be measured in degrees using the Synapse software on radiographic images. The measurement will be performed at baseline, before surgery (T0), and approximately 6 months after surgery (T1), in the operated foot. The change from baseline to 6 months after surgery will be evaluated.
Lateral Meary's Angle Measured Using Synapse
Time frame: Baseline and 6 months after surgery
The lateral Meary's angle will be measured in degrees using the Synapse software on radiographic images. The measurement will be performed at baseline, before surgery (T0), and approximately 6 months after surgery (T1), in the operated foot. The change from baseline to 6 months after surgery will be evaluated.
Lateral Calcaneal Pitch Measured Using Synapse
Time frame: Baseline and 6 months after surgery
The lateral calcaneal pitch will be measured in degrees using the Synapse software on radiographic images. The measurement will be performed at baseline, before surgery (T0), and approximately 6 months after surgery (T1), in the operated foot. The change from baseline to 6 months after surgery will be evaluated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 22196453Brancheau SP, Walker KM, Northcutt DR. An analysis of outcomes after use of the Maxwell-Brancheau Arthroereisis implant. J Foot Ankle Surg. 2012 Jan-Feb;51(1):3-8. doi: 10.1053/j.jfas.2011.10.019.
- Background: PubMed 30598422Indino C, Villafane JH, D'Ambrosi R, Manzi L, Maccario C, Berjano P, Usuelli FG. Effectiveness of subtalar arthroereisis with endorthesis for pediatric flexible flat foot: a retrospective cross-sectional study with final follow up at skeletal maturity. Foot Ankle Surg. 2020 Jan;26(1):98-104. doi: 10.1016/j.fas.2018.12.002. Epub 2018 Dec 21.
- Background: PubMed 27163894Leigheb M, Janicka P, Andorno S, Marcuzzi A, Magnani C, Grassi F. Italian translation, cultural adaptation and validation of the "American Orthopaedic Foot and Ankle Society's (AOFAS) ankle-hindfoot scale". Acta Biomed. 2016 May 6;87(1):38-45.
- Background: PubMed 28058304Atik A, Ozyurek S. Flexible flatfoot. North Clin Istanb. 2014 Aug 3;1(1):57-64. doi: 10.14744/nci.2014.29292. eCollection 2014.
- Background: PubMed 35135510Longo UG, Papalia R, De Salvatore S, Ruzzini L, Candela V, Piergentili I, Oggiano L, Costici PF, Denaro V. Trends in hospitalization for paediatric flatfoot: an Italian nationwide study from 2001 to 2016. BMC Pediatr. 2022 Feb 8;22(1):83. doi: 10.1186/s12887-022-03145-0.
- Background: PubMed 21455468Mosca VS. Flexible flatfoot in children and adolescents. J Child Orthop. 2010 Apr;4(2):107-21. doi: 10.1007/s11832-010-0239-9. Epub 2010 Feb 18.
- Background: PubMed 21445254Fan Y, Fan Y, Li Z, Lv C, Luo D. Natural gaits of the non-pathological flat foot and high-arched foot. PLoS One. 2011 Mar 18;6(3):e17749. doi: 10.1371/journal.pone.0017749.
- Background: PubMed 31195311Shin HS, Lee JH, Kim EJ, Kyung MG, Yoo HJ, Lee DY. Flatfoot deformity affected the kinematics of the foot and ankle in proportion to the severity of deformity. Gait Posture. 2019 Jul;72:123-128. doi: 10.1016/j.gaitpost.2019.06.002. Epub 2019 Jun 5.
- Background: PubMed 35905246Ryu SM, Lee TK, Lee SH. Prevalence of flatfoot among young Korean males and the correlation among flatfoot angles measured in weight-bearing lateral radiographs. Medicine (Baltimore). 2022 Jul 29;101(30):e29720. doi: 10.1097/MD.0000000000029720.
- Background: PubMed 35498774Chen C, Jiang J, Fu S, Wang C, Su Y, Mei G, Xue J, Zou J, Li X, Shi Z. HyProCure for Pediatric Flexible Flatfoot: What Affects the Outcome. Front Pediatr. 2022 Apr 14;10:857458. doi: 10.3389/fped.2022.857458. eCollection 2022.
- Background: PubMed 33332772Wang S, Chen L, Yu J, Zhang C, Huang JZ, Wang X, Ma X. Mid-term Results of Subtalar Arthroereisis with Talar-Fit Implant in Pediatric Flexible Flatfoot and Identifying the Effects of Adjunctive Procedures and Risk Factors for Sinus Tarsi Pain. Orthop Surg. 2021 Feb;13(1):175-184. doi: 10.1111/os.12864. Epub 2020 Dec 17.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pediatric Flexible Flatfoot, run by University of Pavia at 1 site in Italy.
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 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Step-Cycle Duration (time frame: Baseline and 6 months after surgery). The study lists 8 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 NCT07803341, which also lists 11 linked publications.
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 3 Sep 2026.