Normative Data Study of Joints of Healthy ChildrenNCT01387009
Acquisition of Normative Data for Musculoskeletal Ultrasound in Children
An observational study of Normative Data Study of Joints of Healthy Children, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
The primary objective is to establish normative data for Canadian children for the shoulder, elbow, wrist, finger, hip, knee, ankle and toe joint including the relevant tendons surrounding the joint. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Normative Data Study of Joints of Healthy Children
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Dec 2018
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy children will be recruited via invitation by investigators
Who may be able to join
- Healthy children
Who cannot join
- Do not suffer from any condition that might have an effect on their joints.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to establish normative data for Canadian children for the shoulder, elbow, wrist, finger, hip, knee, ankle and toe joint including the relevant tendons surrounding the joint.
Read the detailed description
The respective joints will be assessed through ultrasonography and data will be collected and analyzed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normative Data Study of Joints of Healthy ChildrenStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Johannes Roth, Children's Hospital of Eastern Ontario
- Investigators
- Johannes Roth, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387009
- Sponsor's protocol ID
- IMM 10-0049
- Status last verified
- Jul 2021
- First submitted
- 30 Jun 2011
- Last updated
- 28 Jul 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acquisition of Normative Data for Musculoskeletal Ultrasound in Children
- ClinicalTrials.gov ID
- NCT01387009
- Acronym / sponsor ID
- IMM 10-0049
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jun 2011 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 1 Jul 2011 (estimated)
- 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 primary objective is to establish normative data for Canadian children for the shoulder, elbow, wrist, finger, hip, knee, ankle and toe joint including the relevant tendons surrounding the joint.
Detailed description
The respective joints will be assessed through ultrasonography and data will be collected and analyzed
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy children will be recruited via invitation by investigators
Key inclusion criteria (1 listed)
- Healthy children
Key exclusion criteria (1 listed)
- Do not suffer from any condition that might have an effect on their joints.
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
Not reported in the source record.
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 28 Jul 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.
Johannes Roth principal investigator
Children's Hospital of Eastern Ontario
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 Normative Data Study of Joints of Healthy Children, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
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: finished, as of the sponsor's last update on 28 Jul 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 Canada. 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.
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 28 Jul 2021.