Flat Foot Acquired Bilateral (Pes Planus)ARTRO-LONGNCT07569835
Clinical and Radiological Evaluation Over 10 Years After Bilateral Subtalar Arthrorisis Surgery With Endorthesis and Calcaneal Stop for the Correction of Pediatric Flatfoot
An observational study of Flat Foot Acquired Bilateral (Pes Planus), run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
VARIABLES TO BE COLLECTED AND SOURCE The primary efficacy endpoint will be the maintenance of flatfoot correction over time, assessed both clinically (tip-toe test, Jack test, tip-toe walking test) and radiologically (evaluation of Meary's angle on the lateral foot view and the talocalcaneal angle). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Flat Foot Acquired Bilateral (Pes Planus)
- What is being tested?
- calcaneo stop and endorthesis
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 30 May 2024to May 2026
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Primary objective: To evaluate, at more than ten years' follow-up, the clinical and radiological outcomes of patients who underwent subtalar arthroereisis with calcaneostop and endorthosis for the correction of pediatric flatfoot. Secondary objectives: To compare, within the same patient, the clinical and radiological outcomes of feet treated with subtalar arthroereisis using calcaneostop versus endorthosis.
Who may be able to join
- Patients already in follow-up after undergoing subtalar arthroereisis with calcaneostop and endorthosis, enrolled in the study "Flatfoot treatment: comparison between resorbable endorthosis and resorbable calcaneal stop" by Prof. Giannini, still in follow-up at IOR.
Who cannot join
- Patients who have undergone subsequent surgical procedures on the foot and ankle
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna
Antonio Mazzotti Prof, +39 3498798863, antonio.mazzotti@ior.it
About this study
VARIABLES TO BE COLLECTED AND SOURCE The primary efficacy endpoint will be the maintenance of flatfoot correction over time, assessed both clinically (tip-toe test, Jack test, tip-toe walking test) and radiologically (evaluation of Meary's angle on the lateral foot view and the talocalcaneal angle).
The secondary efficacy endpoint will be the absence of pain at follow-up, assessed using the VAS scale, and evaluation of the footprint using a podoscope.
Read more
TIP-TOE TEST:
The patient is observed under weight-bearing conditions and then while rising onto the toes. If the foot is flexible, the plantar arch-previously absent-reappears when standing on tip-toe.
JACK TEST:
This consists of passive dorsiflexion of the hallux under weight-bearing conditions. If the previously absent arch reappears, the flatfoot is considered flexible.
TIP-TOE WALKING TEST:
The patient walks for about ten steps on tip-toe. The examiner observes any varus alignment of the hindfoot and reconstruction of the plantar arch.
MEARY'S ANGLE:
Measured between the longitudinal axis of the talus and that of the first metatarsal on a weight-bearing lateral foot radiograph.
TALOCALCANEAL ANGLE:
Measured between the longitudinal axis of the talus and that of the calcaneus on a weight-bearing dorsoplantar foot radiograph.
VAS:
The Visual Analog Scale for pain is a tool used to measure the subjective characteristics of pain experienced by the patient, ranging from 0 (no pain) to 10 (worst imaginable pain).
PODOSCOPE FOOTPRINT ASSESSMENT:
Evaluation of the isthmus (the narrow portion of the footprint connecting the heel to the forefoot). The foot is considered normal when the width of the isthmus is between one-third and one-half of the maximum width of the forefoot.
SAMPLE SIZE AND STATISTICS In Prof. Giannini's study, 30 patients were enrolled; approximately 30% were lost to follow-up over 12 years. Barring further losses, about 20 patients currently followed at Clinic I are expected to be available.
ENROLLMENT PROCEDURE Eligible patients will be enrolled in the study only after providing written informed consent. No data collection, procedures, or analyses will be performed prior to obtaining consent.
DATA COLLECTION Clinical data required for the study will be extracted from patients' medical records and source documents.
A dedicated data collection form will be used to record clinical information and the results of the analyses by the study.
For each enrolled patient, a Case Report Form (CRF) will be completed.
- Being tested
- calcaneo stop and endorthesis
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcaneo stop and endorthesisOther
To evaluate, at more than ten years' follow-up, the clinical and radiological outcomes of patients who underwent subtalar arthroereisis with calcaneostop and endorthosis for the correction of pediatric flatfoot.
| Study group | Role | What they receive |
|---|---|---|
| patients who underwent subtalar arthroereisis with calcaneostop and endorthosis | Not described Receives: Other: calcaneo stop and endorthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (Visual Analog Scale)
A scale used to measure the subjective characteristics of pain experienced by the patient, ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: may 2024 may 2027
Secondary outcomes (6)
MEARY'S ANGLE
Measured between the axis of the talus and that of the first metatarsal on a weight-bearing lateral foot radiograph
Measured: may 2024 may 2027
TALO-CALCANEAL ANGLE
Measured between the axis of the talus and that of the calcaneus on a weight-bearing dorsoplantar foot radiograph.
Measured: may 2024 may 2027
TIP-TOE TEST
The patient is observed under weight-bearing conditions and then while rising onto the toes. If the foot is flexible, the plantar arch-previously absent-reappears when standing on tiptoe.
Measured: may2024 - may 2027
jACK TEST
this consists of passive extension of the big toe under weight-bearing. If the previously absent arch reappears, the flatfoot is flexible.
Measured: may 2024 - may 2027
TIPTOE WALKING
The patient walks for about ten steps on tiptoe, and the examiner observes any varus alignment of the hindfoot and the reformation of the plantar arch.
Measured: may 2024 - may 2027
PODOSCOPE FOOTPRINT ASSESSMENT
Evaluation of the isthmus (the narrow portion of the footprint connecting the heel to the forefoot). The foot is considered normal when the width of the isthmus is between one-third and one-half of the maximum width of the
Measured: may 2024 - may 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start30 May 2024
- Primary completion21 Apr 2026
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flat Foot Acquired Bilateral (Pes Planus)Studies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Mazzotti, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569835
- Sponsor's protocol ID
- ARTRO-LONG
- Acronym
- ARTRO-LONG
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Evaluation Over 10 Years After Bilateral Subtalar Arthrorisis Surgery With Endorthesis and Calcaneal Stop for the Correction of Pediatric Flatfoot
- ClinicalTrials.gov ID
- NCT07569835
- Acronym / sponsor ID
- ARTRO-LONG / ARTRO-LONG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 6 May 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.
VARIABLES TO BE COLLECTED AND SOURCE The primary efficacy endpoint will be the maintenance of flatfoot correction over time, assessed both clinically (tip-toe test, Jack test, tip-toe walking test) and radiologically (evaluation of Meary's angle on the lateral foot view and the talocalcaneal angle).
The secondary efficacy endpoint will be the absence of pain at follow-up, assessed using the VAS scale, and evaluation of the footprint using a podoscope.
TIP-TOE TEST:
The patient is observed under weight-bearing conditions and then while rising onto the toes. If the foot is flexible, the plantar arch-previously absent-reappears when standing on tip-toe.
JACK TEST:
This consists of passive dorsiflexion of the hallux under weight-bearing conditions. If the previously absent arch reappears, the flatfoot is considered flexible.
TIP-TOE WALKING TEST:
The patient walks for about ten steps on tip-toe. The examiner observes any varus alignment of the hindfoot and reconstruction of the plantar arch.
MEARY'S ANGLE:
Measured between the longitudinal axis of the talus and that of the first metatarsal on a weight-bearing lateral foot radiograph.
TALOCALCANEAL ANGLE:
Measured between the longitudinal axis of the talus and that of the calcaneus on a weight-bearing dorsoplantar foot radiograph.
VAS:
The Visual Analog Scale for pain is a tool used to measure the subjective characteristics of pain experienced by the patient, ranging from 0 (no pain) to 10 (worst imaginable pain).
PODOSCOPE FOOTPRINT ASSESSMENT:
Evaluation of the isthmus (the narrow portion of the footprint connecting the heel to the forefoot). The foot is considered normal when the width of the isthmus is between one-third and one-half of the maximum width of the forefoot.
SAMPLE SIZE AND STATISTICS In Prof. Giannini's study, 30 patients were enrolled; approximately 30% were lost to follow-up over 12 years. Barring further losses, about 20 patients currently followed at Clinic I are expected to be available.
ENROLLMENT PROCEDURE Eligible patients will be enrolled in the study only after providing written informed consent. No data collection, procedures, or analyses will be performed prior to obtaining consent.
DATA COLLECTION Clinical data required for the study will be extracted from patients' medical records and source documents.
A dedicated data collection form will be used to record clinical information and the results of the analyses by the study.
For each enrolled patient, a Case Report Form (CRF) will be completed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who underwent subtalar arthroereisis with calcaneostop and endorthosis | – | Other: calcaneo stop and endorthesis |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Primary objective: To evaluate, at more than ten years' follow-up, the clinical and radiological outcomes of patients who underwent subtalar arthroereisis with calcaneostop and endorthosis for the correction of pediatric flatfoot. Secondary objectives: To compare, within the same patient, the clinical and radiological outcomes of feet treated with subtalar arthroereisis using calcaneostop versus endorthosis.
Key inclusion criteria (1 listed)
- Patients already in follow-up after undergoing subtalar arthroereisis with calcaneostop and endorthosis, enrolled in the study "Flatfoot treatment: comparison between resorbable endorthosis and resorbable calcaneal stop" by Prof. Giannini, still in follow-up at IOR.
Key exclusion criteria (1 listed)
- Patients who have undergone subsequent surgical procedures on the foot and ankle
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 |
|---|---|---|
| calcaneo stop and endorthesisTo evaluate, at more than ten years' follow-up, the clinical and radiological outcomes of patients who underwent subtalar arthroereisis with calcaneostop and endorthosis for the correction of pediatric flatfoot. | Other | patients who underwent subtalar arthroereisis with calcaneostop and endorthosis |
Primary outcome
VAS (Visual Analog Scale)
Time frame: may 2024 may 2027
A scale used to measure the subjective characteristics of pain experienced by the patient, ranging from 0 (no pain) to 10 (worst imaginable pain).
6 secondary outcomes
MEARY'S ANGLE
Time frame: may 2024 may 2027
TALO-CALCANEAL ANGLE
Time frame: may 2024 may 2027
TIP-TOE TEST
Time frame: may2024 - may 2027
jACK TEST
Time frame: may 2024 - may 2027
TIPTOE WALKING
Time frame: may 2024 - may 2027
PODOSCOPE FOOTPRINT ASSESSMENT
Time frame: may 2024 - may 2027
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 6 May 2026.
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.
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 Flat Foot Acquired Bilateral (Pes Planus), run by Istituto Ortopedico Rizzoli 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 May 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?
Contact Antonio Mazzotti Prof (+39 3498798863, antonio.mazzotti@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (Visual Analog Scale) (time frame: may 2024 may 2027). 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 6 May 2026.