Rotator Cuff TearNCT01085942
Longitudinal Study of Asymptomatic Rotator Cuff Tears
An observational study of Rotator Cuff Tear, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
The purpose of this study is to analyze the natural course of asymptomatic rotator cuff tears. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2008to Aug 2011
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects identified with an asymptomatic rotator cuff tear
Who may be able to join
- Subjects with an asymptomatic rotator cuff tear at least in one shoulder, tear demonstrated both on MRI and sonography, ASES score exceeding 90 points
Who cannot join
- Earlier periods with shoulder pain and dysfunction, earlier treatment for shoulder problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Study of Asymptomatic Rotator Cuff Tears. A Eight Year Follow-up of Symptomatic Status and Tear Characteristics Like Tear Size, Muscle Atrophy and Fatty Degeneration
The purpose of this study is to analyze the natural course of asymptomatic rotator cuff tears.
Read the detailed description
Fifty subjects with an asymptomatic rotator cuff tear were identified in an earlier study. Clinical, sonographic and MRI reexamination of these subjects is performed after an interval of three years. Findings of interest include: (1) the symptomatic status of the subjects (still asymptomatic or symptomatic); (2)tear size on sonography and MRI (unchanged or increased); (3)degree of muscle atrophy on MRI (unchanged or deteriorated); (4)degree of fatty muscle degeneration on MRI (unchanged or deteriorated). We want to analyze whether a change in these tear characteristics is associated with a change of the symptomatic status of these subjects.
- Conditions
- Rotator Cuff Tear
- Keywords
- rotator cuff tear, asymptomatic, natural course, tear characteristics, Asymptomatic rotator cuff tears, Natural course of rotator cuff tears
- 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 |
|---|---|---|
| Asymptomatic rotator cuff tear | Subjects identified with an asymptomatic rotator cuff tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms from a rotator cuff tear
The symptomatic status of initially asymptomatic rotator cuff tears is followed up by reexamination after three and eight years
Measured: 8 years
Tear characteristics on MRI and sonography
Tear characteristics from initially asymptomatic rotator cuff tears are followed up by reexamination by MRI and sonography after three and eight years
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startOct 2008
- Primary completionJun 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Moosmayer, Vestre Viken Hospital Trust
- Investigators
- Stefan Moosmayer, MD, Principal investigator, Vestre Viken Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085942
- Sponsor's protocol ID
- 288-05082 (REK)
- Other IDs
- 2006049
- Status last verified
- Jan 2018
- First submitted
- 11 Mar 2010
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Keener JD. Surveillance of conservatively treated rotator cuff tears is warranted. Commentary on an article by Stefan Moosmayer, MD, PhD, et al.: "The natural history of asymptomatic rotator cuff tears. a three-year follow-up of fifty cases". J Bone Joint Surg Am. 2013 Jul 17;95(14):e101 1-2. doi: 10.2106/JBJS.M.00526. No abstract available.
PubMed 23864184Moosmayer S, Smith HJ, Tariq R, Larmo A. Prevalence and characteristics of asymptomatic tears of the rotator cuff: an ultrasonographic and clinical study. J Bone Joint Surg Br. 2009 Feb;91(2):196-200. doi: 10.1302/0301-620X.91B2.21069.
PubMed 19190053Moosmayer S, Tariq R, Stiris MG, Smith HJ. MRI of symptomatic and asymptomatic full-thickness rotator cuff tears. A comparison of findings in 100 subjects. Acta Orthop. 2010 Jun;81(3):361-6. doi: 10.3109/17453674.2010.483993.
PubMed 20450423Moosmayer S, Tariq R, Stiris M, Smith HJ. The natural history of asymptomatic rotator cuff tears: a three-year follow-up of fifty cases. J Bone Joint Surg Am. 2013 Jul 17;95(14):1249-55. doi: 10.2106/JBJS.L.00185.
PubMed 23864172
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Asymptomatic Rotator Cuff Tears. A Eight Year Follow-up of Symptomatic Status and Tear Characteristics Like Tear Size, Muscle Atrophy and Fatty Degeneration
- ClinicalTrials.gov ID
- NCT01085942
- Acronym / sponsor ID
- 288-05082 (REK)
- Conditions
- Rotator Cuff Tear
- Keywords
- rotator cuff tear, asymptomatic, natural course, tear characteristics, Asymptomatic rotator cuff tears, Natural course of rotator cuff tears
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 12 Mar 2010 (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 purpose of this study is to analyze the natural course of asymptomatic rotator cuff tears.
Detailed description
Fifty subjects with an asymptomatic rotator cuff tear were identified in an earlier study. Clinical, sonographic and MRI reexamination of these subjects is performed after an interval of three years. Findings of interest include: (1) the symptomatic status of the subjects (still asymptomatic or symptomatic); (2)tear size on sonography and MRI (unchanged or increased); (3)degree of muscle atrophy on MRI (unchanged or deteriorated); (4)degree of fatty muscle degeneration on MRI (unchanged or deteriorated). We want to analyze whether a change in these tear characteristics is associated with a change of the symptomatic status of these subjects.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic rotator cuff tear | – | –Subjects identified with an asymptomatic rotator cuff tear |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects identified with an asymptomatic rotator cuff tear
Key inclusion criteria (1 listed)
- Subjects with an asymptomatic rotator cuff tear at least in one shoulder, tear demonstrated both on MRI and sonography, ASES score exceeding 90 points
Key exclusion criteria (1 listed)
- Earlier periods with shoulder pain and dysfunction, earlier treatment for shoulder problems
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
Symptoms from a rotator cuff tear
Time frame: 8 years
The symptomatic status of initially asymptomatic rotator cuff tears is followed up by reexamination after three and eight years
Tear characteristics on MRI and sonography
Time frame: 8 years
Tear characteristics from initially asymptomatic rotator cuff tears are followed up by reexamination by MRI and sonography after three and eight years
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 23 Jan 2018.
- Background: PubMed 23864184Keener JD. Surveillance of conservatively treated rotator cuff tears is warranted. Commentary on an article by Stefan Moosmayer, MD, PhD, et al.: "The natural history of asymptomatic rotator cuff tears. a three-year follow-up of fifty cases". J Bone Joint Surg Am. 2013 Jul 17;95(14):e101 1-2. doi: 10.2106/JBJS.M.00526. No abstract available.
- Results publication: PubMed 19190053Moosmayer S, Smith HJ, Tariq R, Larmo A. Prevalence and characteristics of asymptomatic tears of the rotator cuff: an ultrasonographic and clinical study. J Bone Joint Surg Br. 2009 Feb;91(2):196-200. doi: 10.1302/0301-620X.91B2.21069.
- Results publication: PubMed 20450423Moosmayer S, Tariq R, Stiris MG, Smith HJ. MRI of symptomatic and asymptomatic full-thickness rotator cuff tears. A comparison of findings in 100 subjects. Acta Orthop. 2010 Jun;81(3):361-6. doi: 10.3109/17453674.2010.483993.
- Results publication: PubMed 23864172Moosmayer S, Tariq R, Stiris M, Smith HJ. The natural history of asymptomatic rotator cuff tears: a three-year follow-up of fifty cases. J Bone Joint Surg Am. 2013 Jul 17;95(14):1249-55. doi: 10.2106/JBJS.L.00185.
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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.
Stefan Moosmayer, MD principal investigator
Vestre Viken Hospital Trust
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 Rotator Cuff Tear, run by Vestre Viken Hospital Trust at 1 site in Norway.
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 23 Jan 2018. 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 Norway. 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?
Symptoms from a rotator cuff tear (time frame: 8 years). 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?
On the ClinicalTrials.gov record for NCT01085942, which also lists 4 linked publications.
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 23 Jan 2018.