Rotator Cuff TearNCT03358316
Correlation Analysis Between Rotator Cuff Tear and the Superior Migration of Humeral Head
An observational study of Rotator Cuff Tear, run by Peking University People's Hospital.
Trial summary
To evaluate the association between rotator cuff tear and the proximal migration of humeral head Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rotator Cuff Tear
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Jan 2019
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 60 patients with cuff tear
Who may be able to join
- Patient receive Magnetic Resonance Imaging half year before enrollment, showing supraspinatus tear
- Patient receive X-ray half year before enrollment
- the duration between the two examinations was no longer than 1 week
- no past history of surgery in the selected shoulders
Who cannot join
- patients who cannot receive MRI.
Trial locations and contacts
No sites are listed yet.
About this study
To evaluate the association between rotator cuff tear and the proximal migration of humeral head
Read the detailed description
In this research, 60 patients with unilateral rotator cuff tear in Peking University People's Hospital in 2018 are planned to be recruited .They will receive Magnetic Resonance Imaging(MRI) and X-ray of the painful shoulder before enrollment in this study, the duration between the two examinations was no longer than 1 week, also there is no past history of surgery in the selected shoulders. There is no other exclusion criteria. Upward Migration Index(UMI) is the ratio between the distance of humeral head center to the lower surface of acromion, and the radius of humeral head circle. It can help to minimize the effect of anatomy difference and imaging magnification, compared with the traditional acromiohumeral distance(AHD). Then we use the Spearman correlation analysis to evaluate the relationship between UMI and fatty degeneration, rotator cuff tear size and the thickness of ruptured supraspinatus tendon from X-ray and MRI.
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator Cuff Tear, Magnetic Resonance Imaging, humeral migration
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cuff tear patients | Patients with cuff tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between rotator cuff tear size and the superior migration of humeral head
Correlation between rotator cuff tear size and the superior migration of humeral head
Measured: 1 year
Secondary outcomes (1)
Correlation between rotator cuff fatty degeneration and the superior migration
Correlation between rotator cuff fatty degeneration and the superior migration
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jan 2019 (estimated)
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 Peking University People's HospitalThe 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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Yichong, Peking University People's Hospital
- Investigators
- Yichong Zhang, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358316
- Sponsor's protocol ID
- PKUPH-CRT
- Status last verified
- Nov 2017
- First submitted
- 26 Nov 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- 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 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Analysis Between Rotator Cuff Tear and the Superior Migration of Humeral Head
- ClinicalTrials.gov ID
- NCT03358316
- Acronym / sponsor ID
- PKUPH-CRT
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator Cuff Tear, Magnetic Resonance Imaging, humeral migration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 30 Nov 2017 (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.
To evaluate the association between rotator cuff tear and the proximal migration of humeral head
Detailed description
In this research, 60 patients with unilateral rotator cuff tear in Peking University People's Hospital in 2018 are planned to be recruited .They will receive Magnetic Resonance Imaging(MRI) and X-ray of the painful shoulder before enrollment in this study, the duration between the two examinations was no longer than 1 week, also there is no past history of surgery in the selected shoulders. There is no other exclusion criteria. Upward Migration Index(UMI) is the ratio between the distance of humeral head center to the lower surface of acromion, and the radius of humeral head circle. It can help to minimize the effect of anatomy difference and imaging magnification, compared with the traditional acromiohumeral distance(AHD). Then we use the Spearman correlation analysis to evaluate the relationship between UMI and fatty degeneration, rotator cuff tear size and the thickness of ruptured supraspinatus tendon from X-ray and MRI.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cuff tear patients | – | –Patients with cuff tear |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 60 patients with cuff tear
Key inclusion criteria (4 listed)
- Patient receive Magnetic Resonance Imaging half year before enrollment, showing supraspinatus tear
- Patient receive X-ray half year before enrollment
- the duration between the two examinations was no longer than 1 week
- no past history of surgery in the selected shoulders
Key exclusion criteria (1 listed)
- patients who cannot receive MRI.
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
Correlation between rotator cuff tear size and the superior migration of humeral head
Time frame: 1 year
Correlation between rotator cuff tear size and the superior migration of humeral head
1 secondary outcome
Correlation between rotator cuff fatty degeneration and the superior migration
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- 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.
Yichong Zhang, MD principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear, run by Peking University People's Hospital.
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 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Yichong Zhang, MD (15210802766, 875274428@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between rotator cuff tear size and the superior migration of humeral head (time frame: 1 year). 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 2 Dec 2017.