Subtalar ArthrorisisNCT06091371
Arthrorisis of the Subtalar Joint With a Polymeric Endorthesis for Flexible Flatfoot Treatment During the Growth Age Prospective Evaluation
An observational study of Subtalar Arthrorisis and Flat Feet, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Arthrorisis of the subastragalus joint represents one of the surgical treatments for addressing flexible flatfoot, a condition caused by joint deformity. The device is designed to restore the correct joint relationships between the astragalus and calcaneus, with the goal of maintaining the new and proper joint… Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Subtalar Arthrorisis, Flat Feet, Growth Age
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2022to Jan 2028
- How long will I take part?
- 6 Years
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients aged between 8 and 14 years with idiopathic, flexible, symptomatic flatfoot
Who may be able to join
- Idiopathic, flexible, symptomatic flatfoot
- Patients aged between 8 and 14 years
Who cannot join
- Joint laxity
- Neuromuscular disorders
- Neurological conditions
- Traumatic sequelae
- Iatrogenic flatfoot
- Congenital flatfoot due to tarsal synostosis
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, 40136
Cesare Faldini, MD
About this study
Official title: Prospective Evaluation of Patients Undergoing Surgical Treatment for Arthrorisis of the Subtalar Joint With a Polymeric Endorthesis for the Treatment of Flexible Flatfoot in the Growth Age
Arthrorisis of the subastragalus joint represents one of the surgical treatments for addressing flexible flatfoot, a condition caused by joint deformity. The device is designed to restore the correct joint relationships between the astragalus and calcaneus, with the goal of maintaining the new and proper joint alignment over time, typically allowing for bone remodeling along natural growth lines, usually within a few years.
Several implants and various variations of the procedure have been developed.There are currently no prospective studies that assess radiographic and clinical data over time. Therefore, the purpose of this study is to prospectively analyze the outcomes of surgical intervention using subastragalus arthrorisis with a polymeric endorthesis for the treatment of flexible flatfoot during the growth period in a consecutive series of 55 patients.
- Conditions
- Subtalar Arthrorisis, Flat Feet, Growth Age
- Medical subject headings
- Flatfoot
What is being measured
The primary outcome is the main question the study is designed to answer.
Meary's angle
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
Measured: At baseline (day 0)
Meary's angle
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
Measured: After 1 month
Meary's angle
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
Measured: After 3 months
Meary's angle
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
Measured: After 6 months
Meary's angle
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
Measured: After 12 months
Meary's angle
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
Measured: After 24 months
Meary's angle
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
Measured: After 36 months
Meary's angle
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
Measured: After 48 months
Meary's angle
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
Measured: After 72 months
Secondary outcomes (9)
AOFAS Score
The American Orthopedic Foot and Ankle Society Score is a semi-objective rating scale that evaluates ankle pain, motion and alignment and ranges from 0 to 100 points. 0 worst possible score, 100 best possible score
Measured: At baseline (day 0)
AOFAS Score
The American Orthopedic Foot and Ankle Society Score is a semi-objective rating scale that evaluates ankle pain, motion and alignment and ranges from 0 to 100 points. 0 worst possible score, 100 best possible score
Measured: After 1 month
AOFAS Score
The American Orthopedic Foot and Ankle Society Score is a semi-objective rating scale that evaluates ankle pain, motion and alignment and ranges from 0 to 100 points. 0 worst possible score, 100 best possible score
Measured: After 3 months
AOFAS Score
The American Orthopedic Foot and Ankle Society Score is a semi-objective rating scale that evaluates ankle pain, motion and alignment and ranges from 0 to 100 points. 0 worst possible score, 100 best possible score
Measured: After 6 months
AOFAS Score
American Orthopaedic Foot and Ankle Society Score- from 0 to 100 points. 0 worst possible score, 100 best possible score
Measured: After 12 months
AOFAS Score
American Orthopaedic Foot and Ankle Society Score- from 0 to 100 points. 0 worst possible score, 100 best possible score
Measured: After 24 months
AOFAS Score
American Orthopaedic Foot and Ankle Society Score- from 0 to 100 points. 0 worst possible score, 100 best possible score
Measured: After 36 months
AOFAS Score
American Orthopaedic Foot and Ankle Society Score- from 0 to 100 points. 0 worst possible score, 100 best possible score
Measured: After 48 months
AOFAS Score
American Orthopaedic Foot and Ankle Society Score- from 0 to 100 points. 0 worst possible score, 100 best possible score
Measured: After 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Jul 2022
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
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 Subtalar ArthrorisisStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
- Target duration
- 6 Years
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
- NCT06091371
- Sponsor's protocol ID
- EPProsp
- Status last verified
- Jul 2024
- First submitted
- 13 Oct 2023
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nelson SC, Haycock DM, Little ER. Flexible flatfoot treatment with arthroereisis: radiographic improvement and child health survey analysis. J Foot Ankle Surg. 2004 May-Jun;43(3):144-55. doi: 10.1053/j.jfas.2004.03.012.
PubMed 15181430
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Patients Undergoing Surgical Treatment for Arthrorisis of the Subtalar Joint With a Polymeric Endorthesis for the Treatment of Flexible Flatfoot in the Growth Age
- ClinicalTrials.gov ID
- NCT06091371
- Acronym / sponsor ID
- EPProsp
- Conditions
- Subtalar Arthrorisis, Flat Feet, Growth Age
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 19 Oct 2023 (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.
Arthrorisis of the subastragalus joint represents one of the surgical treatments for addressing flexible flatfoot, a condition caused by joint deformity. The device is designed to restore the correct joint relationships between the astragalus and calcaneus, with the goal of maintaining the new and proper joint alignment over time, typically allowing for bone remodeling along natural growth lines, usually within a few years.
Several implants and various variations of the procedure have been developed.There are currently no prospective studies that assess radiographic and clinical data over time. Therefore, the purpose of this study is to prospectively analyze the outcomes of surgical intervention using subastragalus arthrorisis with a polymeric endorthesis for the treatment of flexible flatfoot during the growth period in a consecutive series of 55 patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Years
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients aged between 8 and 14 years with idiopathic, flexible, symptomatic flatfoot
Key inclusion criteria (2 listed)
- Idiopathic, flexible, symptomatic flatfoot
- Patients aged between 8 and 14 years
Key exclusion criteria (6 listed)
- Joint laxity
- Neuromuscular disorders
- Neurological conditions
- Traumatic sequelae
- Iatrogenic flatfoot
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
Meary's angle
Time frame: At baseline (day 0)
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
Meary's angle
Time frame: After 1 month
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
Meary's angle
Time frame: After 3 months
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
Meary's angle
Time frame: After 6 months
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
Meary's angle
Time frame: After 12 months
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
Meary's angle
Time frame: After 24 months
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
Meary's angle
Time frame: After 36 months
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
Meary's angle
Time frame: After 48 months
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
Meary's angle
Time frame: After 72 months
Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
9 secondary outcomes
AOFAS Score
Time frame: At baseline (day 0)
AOFAS Score
Time frame: After 1 month
AOFAS Score
Time frame: After 3 months
AOFAS Score
Time frame: After 6 months
AOFAS Score
Time frame: After 12 months
AOFAS Score
Time frame: After 24 months
AOFAS Score
Time frame: After 36 months
AOFAS Score
Time frame: After 48 months
AOFAS Score
Time frame: After 72 months
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 2 Aug 2024.
- Results publication: PubMed 15181430Nelson SC, Haycock DM, Little ER. Flexible flatfoot treatment with arthroereisis: radiographic improvement and child health survey analysis. J Foot Ankle Surg. 2004 May-Jun;43(3):144-55. doi: 10.1053/j.jfas.2004.03.012.
- Individual participant dataSharing planned: No
Related trials for Subtalar Arthrorisis
RecruitingObservational study
Clinical and Radiological Evaluation Over 10 Years After Bilateral Subtalar Arthrorisis Surgery With Endorthesis and Calcaneal Stop for the Correction of Pediatric Flatfoot
Flat Foot Acquired Bilateral (Pes Planus)
RecruitingObservational study
Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Reabsorbable Endorthesis Implant in PLLA
Lower Limb Deformity
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 Subtalar Arthrorisis and Flat Feet, 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 2 inclusion and 6 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 2 Aug 2024. 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, MD PhD (0516445064, antonio.mazzotti@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meary's angle (time frame: At baseline (day 0)). The study lists 9 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 NCT06091371, 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 2 Aug 2024.