Calcaneonavicular CoalitionNCT04894942
Evaluation of Clinical Features and Surgical Outcomes of the Too Long Anterior Process in Children
An observational study of Calcaneonavicular Coalition, run by University Hospital, Limoges at 1 site in France.
Trial summary
Calcaneonavicular coalition represents approximately 1% of the population between 8 and 12 years. They are manifested by repeated ankle sprains or by pain. - The diagnosis is radiological on an X-ray of the foot in oblique-3/4 incidence as well as magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Calcaneonavicular Coalition
- What is being tested?
- American Orthopaedic Foot and Ankle Society Score (AOFASS)
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2021to Dec 2021
- 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 16 years
- All sexes
- Child
Study population: Child <16 years with calcaneonavicular coalition with Magnetic resonance imaging diagnosis and already treated orthopedically in the initial treatment of the coalition
Who may be able to join
- Child <16 years
- Child with calcaneonavicular coalition
- Magnetic resonance imaging diagnosis
- Patient already treated orthopedically in the initial treatment of the coalition
Who cannot join
- Child >=16 years
Trial locations and contacts
1 site in 1 country.
Quentin Ballouhey, MD contact
About this study
Official title: Evaluation of Clinical Features and Surgical Outcomes of the Too Long Anterior Process in Children: a Prospective Study
Calcaneonavicular coalition represents approximately 1% of the population between 8 and 12 years. They are manifested by repeated ankle sprains or by pain. - The diagnosis is radiological on an X-ray of the foot in oblique-3/4 incidence as well as magnetic resonance imaging. Treatment is second-line surgery after failure of orthopedic treatment. This surgery is either by direct approach or by arthroscopy, by performing a bone resection to recreate sufficient space in the joint in question. The patients in this study will only be operated on openly.
- Conditions
- Calcaneonavicular Coalition
- Being tested
- American Orthopaedic Foot and Ankle Society Score (AOFASS)
- Medical subject headings
- Synostoses, tarsal, carpal, and digital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
American Orthopaedic Foot and Ankle Society Score (AOFASS)Other
calculation of the score AOFASS before and after the surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of scores before surgery and after surgery at 1 month, for all the operated patients
Calculation of the American Orthopaedic Foot and Ankle Society Score. This is an instrument for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It combines a clinician-reported and a patient-reported part.
The maximal score is 100 points, indicating no symptoms or impairments.
Measured: 1 month
Comparison of scores before surgery and after surgery at 3 months for all the operated patients
Calculation of the American Orthopaedic Foot and Ankle Society Score. This is an instrument for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It combines a clinician-reported and a patient-reported part.
The maximal score is 100 points, indicating no symptoms or impairments.
Measured: 3 months
Comparison of scores before surgery and after surgery at 1 12 months for all the operated patients
Calculation of the American Orthopaedic Foot and Ankle Society Score. This is an instrument for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It combines a clinician-reported and a patient-reported part.
The maximal score is 100 points, indicating no symptoms or impairments.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study startJul 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcaneonavicular CoalitionStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894942
- Sponsor's protocol ID
- Ballouhey _anterior process
- Status last verified
- Mar 2021
- First submitted
- 9 May 2021
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Features and Surgical Outcomes of the Too Long Anterior Process in Children: a Prospective Study
- ClinicalTrials.gov ID
- NCT04894942
- Acronym / sponsor ID
- Ballouhey _anterior process
- Conditions
- Calcaneonavicular Coalition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 May 2021 (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.
Calcaneonavicular coalition represents approximately 1% of the population between 8 and 12 years. They are manifested by repeated ankle sprains or by pain. - The diagnosis is radiological on an X-ray of the foot in oblique-3/4 incidence as well as magnetic resonance imaging. Treatment is second-line surgery after failure of orthopedic treatment. This surgery is either by direct approach or by arthroscopy, by performing a bone resection to recreate sufficient space in the joint in question. The patients in this study will only be operated on openly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Child <16 years with calcaneonavicular coalition with Magnetic resonance imaging diagnosis and already treated orthopedically in the initial treatment of the coalition
Key inclusion criteria (4 listed)
- Child <16 years
- Child with calcaneonavicular coalition
- Magnetic resonance imaging diagnosis
- Patient already treated orthopedically in the initial treatment of the coalition
Key exclusion criteria (1 listed)
- Child >=16 years
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 |
|---|---|---|
| American Orthopaedic Foot and Ankle Society Score (AOFASS)calculation of the score AOFASS before and after the surgery | Other | – |
Primary outcome
Comparison of scores before surgery and after surgery at 1 month, for all the operated patients
Time frame: 1 month
Calculation of the American Orthopaedic Foot and Ankle Society Score. This is an instrument for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It combines a clinician-reported and a patient-reported part. The maximal score is 100 points, indicating no symptoms or impairments.
Comparison of scores before surgery and after surgery at 3 months for all the operated patients
Time frame: 3 months
Calculation of the American Orthopaedic Foot and Ankle Society Score. This is an instrument for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It combines a clinician-reported and a patient-reported part. The maximal score is 100 points, indicating no symptoms or impairments.
Comparison of scores before surgery and after surgery at 1 12 months for all the operated patients
Time frame: 12 months
Calculation of the American Orthopaedic Foot and Ankle Society Score. This is an instrument for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It combines a clinician-reported and a patient-reported part. The maximal score is 100 points, indicating no symptoms or impairments.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
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.
Quentin Ballouhey, MD contact
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 Calcaneonavicular Coalition, run by University Hospital, Limoges at 1 site in France.
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 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: status not confirmed, as of the sponsor's last update on 20 May 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quentin Ballouhey, MD (0555049027, quentin.ballouhey@unilim.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of scores before surgery and after surgery at 1 month, for all the operated patients (time frame: 1 month). The study lists 3 primary outcomes in all. 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 20 May 2021.