Flat FeetCSSPORTNCT04269421
Return To Sport Activities in Patients Surgically Treated For Flat Foot in Paeditric Age
An observational study of Flat Feet and Surgery, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The SURGERY of arthrosis of the subtalar joint, carried out between 9 and 12 years of age, the aim is to restore and maintain the physiological alignment between the talus and the calcaneus during bone maturation. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Flat Feet, Surgery, Sports Physical Therapy
- What is being tested?
- calcaneo-stop: arthrosis of the subtalar joint
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2020to 6 Jun 2023
- How long will I take part?
- 4 Years
- 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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: The analysis will be performed on pediatric patients undergoing surgical treatment for correction of idiopathic flatfoot in the Orthopedics Pediatric department of the IRCCS Rizzoli Orthopedic Institute in the years 2016-2017.
Who may be able to join
- Idiopathic Flatfoot;
- Surgical treatment with arthrorisis of subtalar joint;
- Follow-up> 48 months
- Completeness of the clinical-radiographic documentation.
Who cannot join
- Diagnosis of secondary flat valgus foot;
- Flat foot treated with other techniques;
- Incomplete clinical documentation;
- Patients who refuse to undergo the study
Trial locations and contacts
1 site in 1 country.
About this study
The SURGERY of arthrosis of the subtalar joint, carried out between 9 and 12 years of age, the aim is to restore and maintain the physiological alignment between the talus and the calcaneus during bone maturation.
There are few articles in the literature that talk about the return to sport of pediatric patients after surgery. The aim of the study is to review patients operated on remotely kick heel and describe how they return in their sports (resilience, type of activities carried out, recovery times). The aim of this study is to evaluate the clinical and functional results of patients of age Pediatric treated in the investigator's SC Orthopedics Pediatric Traumatology department for flat feet with "calcaneostop" surgery. The study aims to describe the method of resuming sports activities, analyzing the timing and difficulties declared by patients after surgery, with the help of specific questionnaires.
- Conditions
- Flat Feet, Surgery, Sports Physical Therapy
- Being tested
- calcaneo-stop: arthrosis of the subtalar joint
- 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: arthrosis of the subtalar jointProcedure or surgery
Also called arthrosis of the subtalar joint
arthrosis of the subtalar joint with a screw in the talus bone to stop pathological pronation of the heel
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patiens Able to Return to Sport After Surgery
timing, sport level, resilience
Measured: 1 year
Secondary outcomes (1)
plantar arch index
The plantar arch index establishes a relationship between the central and posterior regions of the footprint, and it is calculated as follows:A line is drawn tangent to the medial forefoot edge and at the heel region.
The mean point of this line is calculated. From this mean point, a perpendicular line is drawn crossing the footprint. The same procedure is repeated at the heel tangency. Measurements are obtained of the width of the central region of the footprint (A) and of the heel region (B) in millimeters.
The plantar arch index is calculated by dividing the A value by B (PAI = A/B).
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 posted13 Feb 2020
- Study start1 Mar 2020
- Primary completion30 Nov 2020
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flat FeetStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Trisolino, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269421
- Sponsor's protocol ID
- CSSPORT
- Acronym
- CSSPORT
- Status last verified
- Jun 2023
- First submitted
- 10 Feb 2020
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return To Sport Activities in Patients Surgically Treated For Flat Foot in Paeditric Age
- ClinicalTrials.gov ID
- NCT04269421
- Acronym / sponsor ID
- CSSPORT / CSSPORT
- Conditions
- Flat Feet, Surgery, Sports Physical Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 13 Feb 2020 (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.
The SURGERY of arthrosis of the subtalar joint, carried out between 9 and 12 years of age, the aim is to restore and maintain the physiological alignment between the talus and the calcaneus during bone maturation.
There are few articles in the literature that talk about the return to sport of pediatric patients after surgery. The aim of the study is to review patients operated on remotely kick heel and describe how they return in their sports (resilience, type of activities carried out, recovery times). The aim of this study is to evaluate the clinical and functional results of patients of age Pediatric treated in the investigator's SC Orthopedics Pediatric Traumatology department for flat feet with "calcaneostop" surgery. The study aims to describe the method of resuming sports activities, analyzing the timing and difficulties declared by patients after surgery, with the help of specific questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The analysis will be performed on pediatric patients undergoing surgical treatment for correction of idiopathic flatfoot in the Orthopedics Pediatric department of the IRCCS Rizzoli Orthopedic Institute in the years 2016-2017.
Key inclusion criteria (4 listed)
- Idiopathic Flatfoot;
- Surgical treatment with arthrorisis of subtalar joint;
- Follow-up> 48 months
- Completeness of the clinical-radiographic documentation.
Key exclusion criteria (4 listed)
- Diagnosis of secondary flat valgus foot;
- Flat foot treated with other techniques;
- Incomplete clinical documentation;
- Patients who refuse to undergo the study
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: arthrosis of the subtalar jointAlso: arthrosis of the subtalar jointarthrosis of the subtalar joint with a screw in the talus bone to stop pathological pronation of the heel | Procedure or surgery | – |
Primary outcome
Number of Patiens Able to Return to Sport After Surgery
Time frame: 1 year
timing, sport level, resilience
1 secondary outcome
plantar arch index
Time frame: 1 year
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 15 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Flat Feet and Surgery, 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 4 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 15 Jun 2023. 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?
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?
Number of Patiens Able to Return to Sport After Surgery (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 15 Jun 2023.