Rotator Cuff TearNCT03567954
The Accuracy of Ultrasound in Detecting Rotator Cuff Tears in Proximal Humerus Fracture Patients
An observational study of Rotator Cuff Tear and Proximal Humeral Fracture, run by University of Aarhus at 2 sites in 2 countries.
Trial summary
The aim of this study is to determine the diagnostic accuracy of ultrasonography (US) in detecting full-thickness (a lesion that extends through both the bursal and articular part of the tendon) rotator cuff tear in patients who have sustained a proximal humerus fracture, using operative examination as the golden… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear, Proximal Humeral Fracture
- What is being tested?
- Ultrasound examination of the rotator cuff tendons
- How many people
- 25 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Jun 2018to 5 Mar 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adults referred to Viborg Regional Hospital and Tampere University Hospital, Finland, under suspicion of a proximal humerus fracture.
Who may be able to join
- Displaced proximal humeral fracture
- Referred to operative treatment
Who cannot join
- Younger than 18 years old
- Non-independent
- Does no understand written and spoken guidance in local language, Danish, Swedish or Finnish
- Open fracture
- Isolated tuberculum fracture
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: The Diagnostic Accuracy of Ultrasound in Detecting Rotator Cuff Tears in Patients Who Sustained a Proximal Humerus Fracture
The aim of this study is to determine the diagnostic accuracy of ultrasonography (US) in detecting full-thickness (a lesion that extends through both the bursal and articular part of the tendon) rotator cuff tear in patients who have sustained a proximal humerus fracture, using operative examination as the golden standard.
Read the detailed description
Although most of the focus concerning proximal humerus fractures is on the bony structures, injuries in the musculotendinous insertion regions of the rotator cuff musculature may also need attention in the treatment. Ultrasound is a painless and non-invasive screening modality in patients with a suspected rotator cuff tear. It is a user-dependent modality and health professionals must possess the competence and training before using it. To the investigators knowledge, no studies have investigated the accuracy of ultrasound in detecting rotator cuff tears, in patients who sustained a proximal humerus fracture.
- Conditions
- Rotator Cuff Tear, Proximal Humeral Fracture
- Being tested
- Ultrasound examination of the rotator cuff tendons
- Keywords
- Diagnostic ultrasound
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examination of the rotator cuff tendonsDiagnostic test
An ultrasound scan of the rotator cuff tendons will be performed to determine the presence of a rotator cuff tear or not
What is being measured
The primary outcome is the main question the study is designed to answer.
Full-thickness rotator cuff tear in the shoulder
The outcome is dichotomous; yes/no and will be used to estimate the sensitivity, specificity, the negative predictive value and the positive predictive value
Measured: Ultrasound scan is performed once; Baseline (prior to operation which is the golden standard)
Secondary outcomes (1)
Partial-thickness rotator cuff tear in the shoulder
The outcome is dichotomous; yes/no and will be used to estimate the sensitivity, specificity, the negative predictive value and the positive predictive value
Measured: Ultrasound scan is performed once; Baseline (prior to operation which is the golden standard)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start22 Jun 2018
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
Why it stopped: Low inclusionrate due to logistic challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Viborg, Skive, Tampere University Hospital
- Responsible party
- Sponsor
- Investigators
- Helle Østergaard, MSc., PhD student, Principal investigator, Viborg Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567954
- Sponsor's protocol ID
- ProxHumUS
- Status last verified
- Dec 2022
- First submitted
- 25 May 2018
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Accuracy of Ultrasound in Detecting Rotator Cuff Tears in Patients Who Sustained a Proximal Humerus Fracture
- ClinicalTrials.gov ID
- NCT03567954
- Acronym / sponsor ID
- ProxHumUS
- Conditions
- Rotator Cuff Tear, Proximal Humeral Fracture
- Keywords
- Diagnostic ultrasound
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low inclusionrate due to logistic challenges
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Regionshospitalet Viborg, Skive, Tampere University Hospital
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 26 Jun 2018 (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 aim of this study is to determine the diagnostic accuracy of ultrasonography (US) in detecting full-thickness (a lesion that extends through both the bursal and articular part of the tendon) rotator cuff tear in patients who have sustained a proximal humerus fracture, using operative examination as the golden standard.
Detailed description
Although most of the focus concerning proximal humerus fractures is on the bony structures, injuries in the musculotendinous insertion regions of the rotator cuff musculature may also need attention in the treatment. Ultrasound is a painless and non-invasive screening modality in patients with a suspected rotator cuff tear. It is a user-dependent modality and health professionals must possess the competence and training before using it. To the investigators knowledge, no studies have investigated the accuracy of ultrasound in detecting rotator cuff tears, in patients who sustained a proximal humerus fracture.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adults referred to Viborg Regional Hospital and Tampere University Hospital, Finland, under suspicion of a proximal humerus fracture.
Key inclusion criteria (2 listed)
- Displaced proximal humeral fracture
- Referred to operative treatment
Key exclusion criteria (5 listed)
- Younger than 18 years old
- Non-independent
- Does no understand written and spoken guidance in local language, Danish, Swedish or Finnish
- Open fracture
- Isolated tuberculum fracture
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 examination of the rotator cuff tendonsAn ultrasound scan of the rotator cuff tendons will be performed to determine the presence of a rotator cuff tear or not | Diagnostic test | – |
Primary outcome
Full-thickness rotator cuff tear in the shoulder
Time frame: Ultrasound scan is performed once; Baseline (prior to operation which is the golden standard)
The outcome is dichotomous; yes/no and will be used to estimate the sensitivity, specificity, the negative predictive value and the positive predictive value
1 secondary outcome
Partial-thickness rotator cuff tear in the shoulder
Time frame: Ultrasound scan is performed once; Baseline (prior to operation which is the golden standard)
Results and safety
The study was stopped early (reason given: Low inclusionrate due to logistic challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Helle Østergaard, MSc., PhD student principal investigator
Viborg Regional Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear and Proximal Humeral Fracture, run by University of Aarhus at 2 sites in 2 countries.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Finland. 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 was stopped early (reason given: Low inclusionrate due to logistic challenges). Results are not available in the source record.
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?
Full-thickness rotator cuff tear in the shoulder (time frame: Ultrasound scan is performed once; Baseline (prior to operation which is the golden standard)). 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 8 Mar 2024.