Tendon DisorderNCT04204369
A Musculoskeletal Ultrasound Course for Orthopedic Surgery Residents
A study testing Ultrasound education curriculum in people with Tendon Disorder, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
A group of orthopedic surgery residents underwent a structured online and practical musculoskeletal ultrasound course. Their proficiency on a written and practical exam, as well as frequency and comfort when using was recorded prior to the course, immediately after, and 6 months after the course. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tendon Disorder
- What is being tested?
- Ultrasound education curriculum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 6 Nov 2017to 6 Jul 2018
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Be an orthopedic surgery resident
- Training at the University of Manitoba
- Post-graduate year (PGY) one to five
Who cannot join
- Residents having less than six months of training left before graduation
- Residents on extended leave (for example: completing graduate studies abroad, parental leave, and sabbatical)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usefulness of a Musculoskeletal Ultrasound Course in an Orthopedic Surgery Residency Training Program
A group of orthopedic surgery residents underwent a structured online and practical musculoskeletal ultrasound course. Their proficiency on a written and practical exam, as well as frequency and comfort when using was recorded prior to the course, immediately after, and 6 months after the course.
Read the detailed description
Musculoskeletal ultrasound (MSK-US) can have many uses for orthopedic surgeons, such as assisting in clinical diagnosis for muscle, tendon and ligament injuries, providing direct guidance for joint injections, or assessing the adequacy of a reduction in the emergency department. However, proficiency in sonography is not a requirement for certification in orthopedic surgery in Canada, and orthopedic trainees are rarely exposed to the subject. This project aims assess the usefulness in clinical education of a newly implemented MSK-US course in an orthopedic surgery program.
An MSK-US course for orthopedic surgery residents has been developed. An online survey covering the level of training of the resident, their prior experience with ultrasound (number of times used by month) and their comfort level with different parts of the examination (numeric analog scale - NAS), was filled by the participants prior to the course. A pre-course written and practical test was also given to the residents. Following the course, the participants were reassessed with the same tests and surveys on the same day as the course, and at 6 months post. Change in frequency of use, comfort level and test scores were assessed using a Kruskal-Wallis ANOVA and post-hoc Wilcoxon tests.
It was expected that residents' frequency of use, comfort level and tests scores would improve following the implementation of the course. The results were expected to be maintained at the 6 months endpoint.
- Conditions
- Tendon Disorder
- Being tested
- Ultrasound education curriculum
- Keywords
- point of care ultrasound, musculoskeletal ultrasound, sonography, resident education, orthopaedic surgery, online curriculum
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound education curriculumOther
Participants were enrolled in a musculoskeletal ultrasound course including 2 components:
- An online course (1-2 hours) to be done before the practical session. The videos were made available one (1) month prior to the practical course. This component reviewed the basics of ultrasonography, as well as the normal and abnormal appearance of relevant musculoskeletal structures (bone, tendon, ligaments, muscles, bursas, and nerves), and the ultrasound anatomy of high yield regions of the musculoskeletal system (shoulder, elbow, knee, ankle)
- A practical session (4-6 hours) done during one of the usual academic days of the orthopedic residency program. This session covered the use of the ultrasound; the examination of the shoulder, elbow, knee, and ankle; ultrasound-guided musculoskeletal injections and aspirations; and ultrasound-guided distal radius fracture reductions. Ample practice time was given to the residents using means such as phantom models, cadavers, and real patients.
| Study group | Role | What they receive |
|---|---|---|
| Teaching arm | Experimental | This group received the teaching intervention and was evaluated before and after the intervention. Improvement was compared to their performance prior to the intervention. Receives: Other: Ultrasound education curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Musculoskeletal ultrasound knowledge after the course
A 13 questions written examination was given to the residents using an online platform at each endpoint. The exam covered the basics of ultrasound physics; how to use the machine; the normal and pathologic appearance of tendons, ligaments, and muscles; and ultrasound appearance of the musculoskeletal anatomy described in the course. The score was reported on a scale from 0 to 100, with 100 being the best score.
Measured: Before the course (within a month), immediately after the course (same day)
Change in Musculoskeletal ultrasound knowledge at 6 months
A 13 questions written examination was given to the residents using an online platform at each endpoint. The exam covered the basics of ultrasound physics; how to use the machine; the normal and pathologic appearance of tendons, ligaments, and muscles; and ultrasound appearance of the musculoskeletal anatomy described in the course. The score was reported on a scale from 0 to 100, with 100 being the best score.
Measured: Before the course (within a month), 6 months after the course
Secondary outcomes (3)
Practical shoulder ultrasound exam
Each participant underwent a practical examination assessing ultrasound proficiency at each endpoint. The residents were assessed by one of the author of the study on their ability to perform a shoulder ultrasound exam as well as the different tasks related to the MSK-US. For each task, the assessor rated the participant on a scale of 0 to 2, where :
- 0 means an inability to perform the task,
- 1 means the task is only partially completed,
- 2 means that the task that is performed correctly.
The final score was then be calculated and reported in percentage (with 100 being a perfect score) for the analysis.
Measured: Immediately after the course (same day), 6 months after the course
Ultrasound comfort in clinical setting
A questionnaire covering different aspect of ultrasound use by the residents was given using the online platform at each endpoint. The questionnaire inquired about the comfort level when using MSK-US for different examinations and procedure (Numeric Analog Scale from 0 to 10, with 0 being very uncomfortable and 10 being very comfortable). Each numeric analog scale was reported independently and not compound score was created:
- Setting up the ultrasound machine
- Choosing the appropriate probe
- Adjusting the depth and contrast
- Diagnosing a ligament, tendon, muscle, nerve, or bone injury
- Performing a joint injection or aspiration
- Performing an injection or aspiration in any other region than a joint
- Guiding the reduction of a fracture in the forearm
- Guiding the reduction of any other fracture than the forearm
- Performing ultrasound in general
Measured: Before the course (within a month), 6 months after the course
Ultrasound use in clinical setting
The questionnaire inquired about the number of time ultrasound was used in the last 6 months for different examinations and procedures. This was reported as an absolute number for each aspect of ultrasound use:
- Diagnosing a ligament, tendon, muscle, nerve, or bone injury
- Performing a joint injection or aspiration
- Performing an injection or aspiration of any other region than a joint
- Guiding the reduction of a fracture in the adult patient
- Guiding the reduction of a pediatric fracture
Measured: Before the course (within a month), 6 months after the course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start6 Nov 2017
- Primary completion6 Jul 2018
- Study completion6 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendon DisorderStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group receiving intervention. Assessement prior to intervention, immediately after, and at 6 months.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Larrivee, MD-MSc, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204369
- Sponsor's protocol ID
- H2017:227 (HS20921)
- Status last verified
- Dec 2019
- First submitted
- 15 Dec 2019
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to other researcher. Because of the small size of the orthopedic surgery program, sharing IPD would make identification of individuals unavoidable.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of a Musculoskeletal Ultrasound Course in an Orthopedic Surgery Residency Training Program
- ClinicalTrials.gov ID
- NCT04204369
- Acronym / sponsor ID
- H2017:227 (HS20921)
- Conditions
- Tendon Disorder
- Keywords
- point of care ultrasound, musculoskeletal ultrasound, sonography, resident education, orthopaedic surgery, online curriculum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 19 Dec 2019 (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.
A group of orthopedic surgery residents underwent a structured online and practical musculoskeletal ultrasound course. Their proficiency on a written and practical exam, as well as frequency and comfort when using was recorded prior to the course, immediately after, and 6 months after the course.
Detailed description
Musculoskeletal ultrasound (MSK-US) can have many uses for orthopedic surgeons, such as assisting in clinical diagnosis for muscle, tendon and ligament injuries, providing direct guidance for joint injections, or assessing the adequacy of a reduction in the emergency department. However, proficiency in sonography is not a requirement for certification in orthopedic surgery in Canada, and orthopedic trainees are rarely exposed to the subject. This project aims assess the usefulness in clinical education of a newly implemented MSK-US course in an orthopedic surgery program.
An MSK-US course for orthopedic surgery residents has been developed. An online survey covering the level of training of the resident, their prior experience with ultrasound (number of times used by month) and their comfort level with different parts of the examination (numeric analog scale - NAS), was filled by the participants prior to the course. A pre-course written and practical test was also given to the residents. Following the course, the participants were reassessed with the same tests and surveys on the same day as the course, and at 6 months post. Change in frequency of use, comfort level and test scores were assessed using a Kruskal-Wallis ANOVA and post-hoc Wilcoxon tests.
It was expected that residents' frequency of use, comfort level and tests scores would improve following the implementation of the course. The results were expected to be maintained at the 6 months endpoint.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group receiving intervention. Assessement prior to intervention, immediately after, and at 6 months.
| Arm | Type | Receives |
|---|---|---|
| Teaching arm | Experimental | Other: Ultrasound education curriculumThis group received the teaching intervention and was evaluated before and after the intervention. Improvement was compared to their performance prior to the intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Be an orthopedic surgery resident
- Training at the University of Manitoba
- Post-graduate year (PGY) one to five
Key exclusion criteria (2 listed)
- Residents having less than six months of training left before graduation
- Residents on extended leave (for example: completing graduate studies abroad, parental leave, and sabbatical)
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 |
|---|---|---|
| Ultrasound education curriculumParticipants were enrolled in a musculoskeletal ultrasound course including 2 components: * An online course (1-2 hours) to be done before the practical session. The videos were made available one (1) month prior to the practical course. This component reviewed the basics of ultrasonography, as well as the normal and abnormal appearance of relevant musculoskeletal structures (bone, tendon, ligaments, muscles, bursas, and nerves), and the ultrasound anatomy of high yield regions of the musculoskeletal system (shoulder, elbow, knee, ankle) * A practical session (4-6 hours) done during one of the usual academic days of the orthopedic residency program. This session covered the use of the ultrasound; the examination of the shoulder, elbow, knee, and ankle; ultrasound-guided musculoskeletal injections and aspirations; and ultrasound-guided distal radius fracture reductions. Ample practice time was given to the residents using means such as phantom models, cadavers, and real patients. | Other | Teaching arm |
Primary outcome
Change in Musculoskeletal ultrasound knowledge after the course
Time frame: Before the course (within a month), immediately after the course (same day)
A 13 questions written examination was given to the residents using an online platform at each endpoint. The exam covered the basics of ultrasound physics; how to use the machine; the normal and pathologic appearance of tendons, ligaments, and muscles; and ultrasound appearance of the musculoskeletal anatomy described in the course. The score was reported on a scale from 0 to 100, with 100 being the best score.
Change in Musculoskeletal ultrasound knowledge at 6 months
Time frame: Before the course (within a month), 6 months after the course
A 13 questions written examination was given to the residents using an online platform at each endpoint. The exam covered the basics of ultrasound physics; how to use the machine; the normal and pathologic appearance of tendons, ligaments, and muscles; and ultrasound appearance of the musculoskeletal anatomy described in the course. The score was reported on a scale from 0 to 100, with 100 being the best score.
3 secondary outcomes
Practical shoulder ultrasound exam
Time frame: Immediately after the course (same day), 6 months after the course
Ultrasound comfort in clinical setting
Time frame: Before the course (within a month), 6 months after the course
Ultrasound use in clinical setting
Time frame: Before the course (within a month), 6 months after the course
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 19 Dec 2019.
- Individual participant dataSharing planned: No. IPD will not be shared to other researcher. Because of the small size of the orthopedic surgery program, sharing IPD would make identification of individuals unavoidable.
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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.
Samuel Larrivee, MD-MSc principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound education curriculum in people with Tendon Disorder, run by Université de Sherbrooke 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 3 inclusion and 2 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 19 Dec 2019. 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.
What does the primary outcome measure?
Change in Musculoskeletal ultrasound knowledge after the course (time frame: Before the course (within a month), immediately after the course (same day)). 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?
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 19 Dec 2019.