Lower Limb DeformityCS-RMNCT06525532
Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Reabsorbable Endorthesis Implant in PLLA
An observational study of Lower Limb Deformity, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
From the archives of the IRCCS Rizzoli Orthopedic Institute, all cases of arthrorrhesis of the subtalar joint with a reabsorbable endorthotic implant in PLLA will be retrieved. An overall electronic database will be created and all medical records of these cases will be reviewed. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Lower Limb Deformity
- What is being tested?
- follow up
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jun 2024to Dec 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 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric population with subtalar arthrorisis surgery with reabsorbable endorthesis implant in PLLA
Who may be able to join
- Age between 8 and 15 years at the time of surgery
- Arthrorrhosis of the subtalar with reabsorbable endorthotic implant in PLLA
- Minimum follow-up of 5 years
Who cannot join
- Revisions/explantation of the endorthesis device
- Patients with active acute or chronic infections
- Patients with chronic inflammatory joint diseases
- Patients with previous significant trauma of the lower limbs following surgery
- Patients with pre-existing anomalies of ambulatory kinematics (amputations, neuro-muscular diseases, poliomyelitis, hip dysplasias)
- Patients with cognitive deficits
Show all 14Show fewer
- - Patients with concomitant neurological pathologies
- Patients suffering from tumor pathology
- Patients with cardiac pacemakers or other prostheses equipped with electronic circuits
- Patients with intracranial metal implants, metal heart valves, vascular clips, ferromagnetic endovascular filters/stents/coils, Swan-Ganz catheters or in any case positioned close to vital anatomical structures
- Patients with orthopedic metal prostheses
- Patients with cochlear implants or fixed hearing aids, lens prostheses with ferromagnetic intra-ocular points, IUD (coil) or splinters made of ferromagnetic material
- Pregnant patients
- Patients with insulin pumps and non-removable contact lenses
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
Massimiliano Mosca, MD
About this study
Official title: Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Resorbable PLLA Endothesis Implant: Prospective Observational Study at 5 Years of Minimum Follow-up
From the archives of the IRCCS Rizzoli Orthopedic Institute, all cases of arthrorrhesis of the subtalar joint with a reabsorbable endorthotic implant in PLLA will be retrieved. An overall electronic database will be created and all medical records of these cases will be reviewed.
The eligibility of each individual patient will be assessed on the basis of the exclusion and inclusion criteria (non-probability convenience sampling).
The study will not present a control group or comparison groups between therapeutic procedures.
- Conditions
- Lower Limb Deformity
- Being tested
- follow up
- Keywords
- arthrorrhesis, reabsorbable endorthotic implant, subtalar joint, pediatric joint implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow upOther
performing a 3 Tesla MRI of the operated foot
| Study group | Role | What they receive |
|---|---|---|
| Patients | subjects who have undergone surgery for subtalar arthroritis with a reabsorbable endorthotic PLLA implant Receives: Other: follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instrumental evaluation
Instrumental evaluation with 3 Tesla MRI of the degradation and possible resorption of the implant
Measured: At baseline (Day 0)
evaluation of screw resorption
Clinical and Magnetic Resonance Imaging Results - PMC (nih.gov), Poly-L-lactic acid - hydroxyapatite (PLLA-HA) bioabsorbable interference screws for tibial graft fixation in anterior cruciate ligament (ACL) reconstruction surgery
Measured: at baseline
Secondary outcomes (2)
clinical evaluation - Ankle-Hindfoot score
AOFAS: this questionnaire consists of points assigned to nine items divided into three categories: pain (40 points), functional aspects (50 points) and alignment (10 points) for a total of 100 points, the extreme of which represents a normal foot complex -ankle
Measured: at baseline (day 0)
Quality of life - SF-12
The SF-12 health questionnaire is a standardized generic instrument for the rapid, economical and disease-free acquisition of the patient's health-related quality of life.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start12 Jun 2024
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lower Limb DeformityStudies 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
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525532
- Sponsor's protocol ID
- CS-RM
- Acronym
- CS-RM
- Status last verified
- Dec 2025
- First submitted
- 24 Jul 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Benedetti MG, Ceccarelli F, Berti L, Luciani D, Catani F, Boschi M, Giannini S. Diagnosis of flexible flatfoot in children: a systematic clinical approach. Orthopedics. 2011 Jan 1;34(2):94. doi: 10.3928/01477447-20101221-04.
PubMed 21323297Kim MK, Lee YS. Kinematic analysis of the lower extremities of subjects with flat feet at different gait speeds. J Phys Ther Sci. 2013 May;25(5):531-3. doi: 10.1589/jpts.25.531. Epub 2013 Jun 29.
PubMed 24259795
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Resorbable PLLA Endothesis Implant: Prospective Observational Study at 5 Years of Minimum Follow-up
- ClinicalTrials.gov ID
- NCT06525532
- Acronym / sponsor ID
- CS-RM / CS-RM
- Conditions
- Lower Limb Deformity
- Keywords
- arthrorrhesis, reabsorbable endorthotic implant, subtalar joint, pediatric joint implant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Jul 2024 (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.
From the archives of the IRCCS Rizzoli Orthopedic Institute, all cases of arthrorrhesis of the subtalar joint with a reabsorbable endorthotic implant in PLLA will be retrieved. An overall electronic database will be created and all medical records of these cases will be reviewed.
The eligibility of each individual patient will be assessed on the basis of the exclusion and inclusion criteria (non-probability convenience sampling).
The study will not present a control group or comparison groups between therapeutic procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: follow upsubjects who have undergone surgery for subtalar arthroritis with a reabsorbable endorthotic PLLA implant |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric population with subtalar arthrorisis surgery with reabsorbable endorthesis implant in PLLA
Key inclusion criteria (3 listed)
- Age between 8 and 15 years at the time of surgery
- Arthrorrhosis of the subtalar with reabsorbable endorthotic implant in PLLA
- Minimum follow-up of 5 years
Key exclusion criteria (14 listed)
- Revisions/explantation of the endorthesis device
- Patients with active acute or chronic infections
- Patients with chronic inflammatory joint diseases
- Patients with previous significant trauma of the lower limbs following surgery
- Patients with pre-existing anomalies of ambulatory kinematics (amputations, neuro-muscular diseases, poliomyelitis, hip dysplasias)
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 |
|---|---|---|
| follow upperforming a 3 Tesla MRI of the operated foot | Other | Patients |
Primary outcome
Instrumental evaluation
Time frame: At baseline (Day 0)
Instrumental evaluation with 3 Tesla MRI of the degradation and possible resorption of the implant
evaluation of screw resorption
Time frame: at baseline
Clinical and Magnetic Resonance Imaging Results - PMC (nih.gov), Poly-L-lactic acid - hydroxyapatite (PLLA-HA) bioabsorbable interference screws for tibial graft fixation in anterior cruciate ligament (ACL) reconstruction surgery
2 secondary outcomes
clinical evaluation - Ankle-Hindfoot score
Time frame: at baseline (day 0)
Quality of life - SF-12
Time frame: at baseline
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 29 Dec 2025.
- Results publication: PubMed 21323297Benedetti MG, Ceccarelli F, Berti L, Luciani D, Catani F, Boschi M, Giannini S. Diagnosis of flexible flatfoot in children: a systematic clinical approach. Orthopedics. 2011 Jan 1;34(2):94. doi: 10.3928/01477447-20101221-04.
- Results publication: PubMed 24259795Kim MK, Lee YS. Kinematic analysis of the lower extremities of subjects with flat feet at different gait speeds. J Phys Ther Sci. 2013 May;25(5):531-3. doi: 10.1589/jpts.25.531. Epub 2013 Jun 29.
- 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.
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 Lower Limb Deformity, 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 3 inclusion and 14 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 29 Dec 2025. 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 Massimiliano Mosca, MD (0516366, massimiliano.mosca@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Instrumental evaluation (time frame: At baseline (Day 0)). 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 NCT06525532, which also lists 2 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 29 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.