Full-thickness Rotator Cuff TearsNCT01829633
Anatomic and Clinical Long-term Follow-up of Conservatively Treated Rotator Cuff Tears
An observational study of Full-thickness Rotator Cuff Tears, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
Study population: Patients who have been treated with physiotherapy for a potentially repairable rotator cuff tear in the period from 2002 to 2005. Study Method: At the time of diagnosis (2002 to 2005) all study patients were examined clinically, sonographically and by MRI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Full-thickness Rotator Cuff Tears
- What is being tested?
- Physiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 49 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2012to Jul 2017
- 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: Patients diagnosed with a symptomatic full-thickness rotator cuff tear in the period 2002 to 2005. All tears were deemed to be repairable at the time of the diagnosis
Who may be able to join
- Full-thickness rotator cuff tear diagnosed between 2002 and 2005 by both sonography and MRI.
- At the time of diagnosis (2002 to 2005):
- Typical clinical symptoms for a rotator cuff tear including pain laterally on upper humerus, painful arc, positive impingement test (Neer or Hawkins)
- Potentially repairable tear (tear size up to 3 cm, muscle atrophy not exceeding grade 2 according to Thomazeau, fatty degeneration not exceeding grade 1 according to Goutallier).
- Treated by physiotherapy for at least 3 months
Who cannot join
- At the time of diagnosis (2002 to 2005):
- Full-thickness tears of the subscapularis tendon or of the entire supraspinatus and infraspinatus tendons
- Other symptomatic shoulder pathology including long head of the biceps tendon pathology, acromioclavicular joint pathology, shoulder instability, inflammatory diseases, glenohumeral arthritis
- Earlier treated with rotator cuff repair in the study shoulder
Trial locations and contacts
1 site in 1 country.
About this study
Study population: Patients who have been treated with physiotherapy for a potentially repairable rotator cuff tear in the period from 2002 to 2005.
Study Method: At the time of diagnosis (2002 to 2005) all study patients were examined clinically, sonographically and by MRI. Some patients also completed a shoulder score. All study patients will now be reexamined, 8 to 10 years after they were diagnosed. Reexamination includes history taking, clinical examination, completion of three shoulder scores (two shoulder specific scores, one general health score), Sonography and MRI. Findings of interest are
Read more
- the number of relapses during follow-up,
- the need for surgical treatment during follow-up,
- the deterioration of tear anatomy (tear size, muscle atrophy, fatty degeneration) during follow-up
- the actual clinical shoulder condition (as given by shoulder scores) at reexamination.
Study purpose: We want to assess the anatomic and clinical long-term results of physiotherapy for potentially repairable rotator cuff tears. We want to find out if tear anatomy of unrepaired rotator cuff tears deteriorates over time and if such a deterioration is associated with a development of more serious degrees of symptoms.
- Conditions
- Full-thickness Rotator Cuff Tears
- Being tested
- Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyProcedure or surgery
Shoulder physiotherapy with exercises
| Study group | Role | What they receive |
|---|---|---|
| Rotator cuff tears | Patients who were diagnosed with a symptomatic full-thickness tear of the rotator cuff. Tear examination by sonography and MRI showed a repairable tear. All patients were initially treated conservatively by physiotherapy. Receives: Procedure: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder sonography
Sonographic shoulder examination was performed for all study patients before treatment was given. All patients will be reexamined by sonography after 8 to 10 years. The finding of interest is the change of tear size as determined by sonography
Measured: Baseline to 8-10 years follow-up
Secondary outcomes (3)
Number of relapses during follow-up
At follow-up patients have to report how many new periods with shoulder pain they have experienced since the time of diagnosis
Measured: 8 to 10 years
Number of patients who needed surgical treatment of their shoulder during follow-up
At follow-up, patients have to report the number of surgical interventions in their study shoulder since the time of diagnosis.
Measured: 8 to 10 years
MRI of the shoulder
At the time of diagnosis, no patient had serious muscle atrophy or fatty degeneration as determined by MRI. The finding of interest at 8 to 10 years follow-up is the number of patients who have progressed to serious muscle atrophy or fatty degeneration during follow-up.
Measured: MRI will be performed at 8 to 10 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startMar 2012
- Primary completionFeb 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Full-thickness Rotator Cuff TearsStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 49 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, PhD, Principal investigator, Vestre Viken Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829633
- Sponsor's protocol ID
- 29144/3/LT
- Other IDs
- 2011/1931
- Status last verified
- Jan 2018
- First submitted
- 9 Apr 2013
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moosmayer S, Gartner AV, Tariq R. The natural course of nonoperatively treated rotator cuff tears: an 8.8-year follow-up of tear anatomy and clinical outcome in 49 patients. J Shoulder Elbow Surg. 2017 Apr;26(4):627-634. doi: 10.1016/j.jse.2016.10.002. Epub 2017 Jan 12.
PubMed 28089257
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
- Anatomic and Clinical Long-term Follow-up of Conservatively Treated Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT01829633
- Acronym / sponsor ID
- 29144/3/LT
- Conditions
- Full-thickness Rotator Cuff Tears
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 11 Apr 2013 (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.
Study population: Patients who have been treated with physiotherapy for a potentially repairable rotator cuff tear in the period from 2002 to 2005.
Study Method: At the time of diagnosis (2002 to 2005) all study patients were examined clinically, sonographically and by MRI. Some patients also completed a shoulder score. All study patients will now be reexamined, 8 to 10 years after they were diagnosed. Reexamination includes history taking, clinical examination, completion of three shoulder scores (two shoulder specific scores, one general health score), Sonography and MRI. Findings of interest are
- the number of relapses during follow-up,
- the need for surgical treatment during follow-up,
- the deterioration of tear anatomy (tear size, muscle atrophy, fatty degeneration) during follow-up
- the actual clinical shoulder condition (as given by shoulder scores) at reexamination.
Study purpose: We want to assess the anatomic and clinical long-term results of physiotherapy for potentially repairable rotator cuff tears. We want to find out if tear anatomy of unrepaired rotator cuff tears deteriorates over time and if such a deterioration is associated with a development of more serious degrees of symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotator cuff tears | – | Procedure: PhysiotherapyPatients who were diagnosed with a symptomatic full-thickness tear of the rotator cuff. Tear examination by sonography and MRI showed a repairable tear. All patients were initially treated conservatively by physiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with a symptomatic full-thickness rotator cuff tear in the period 2002 to 2005. All tears were deemed to be repairable at the time of the diagnosis
Key inclusion criteria (5 listed)
- Full-thickness rotator cuff tear diagnosed between 2002 and 2005 by both sonography and MRI.
- Typical clinical symptoms for a rotator cuff tear including pain laterally on upper humerus, painful arc, positive impingement test (Neer or Hawkins)
- Potentially repairable tear (tear size up to 3 cm, muscle atrophy not exceeding grade 2 according to Thomazeau, fatty degeneration not exceeding grade 1 according to Goutallier).
- Treated by physiotherapy for at least 3 months
Key exclusion criteria (4 listed)
- Full-thickness tears of the subscapularis tendon or of the entire supraspinatus and infraspinatus tendons
- Other symptomatic shoulder pathology including long head of the biceps tendon pathology, acromioclavicular joint pathology, shoulder instability, inflammatory diseases, glenohumeral arthritis
- Earlier treated with rotator cuff repair in the study shoulder
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 |
|---|---|---|
| PhysiotherapyShoulder physiotherapy with exercises | Procedure or surgery | Rotator cuff tears |
Primary outcome
Shoulder sonography
Time frame: Baseline to 8-10 years follow-up
Sonographic shoulder examination was performed for all study patients before treatment was given. All patients will be reexamined by sonography after 8 to 10 years. The finding of interest is the change of tear size as determined by sonography
3 secondary outcomes
Number of relapses during follow-up
Time frame: 8 to 10 years
Number of patients who needed surgical treatment of their shoulder during follow-up
Time frame: 8 to 10 years
MRI of the shoulder
Time frame: MRI will be performed at 8 to 10 years follow-up
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.
- Results publication: PubMed 28089257Moosmayer S, Gartner AV, Tariq R. The natural course of nonoperatively treated rotator cuff tears: an 8.8-year follow-up of tear anatomy and clinical outcome in 49 patients. J Shoulder Elbow Surg. 2017 Apr;26(4):627-634. doi: 10.1016/j.jse.2016.10.002. Epub 2017 Jan 12.
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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, PhD 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 Full-thickness Rotator Cuff Tears, 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 5 inclusion and 4 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?
Shoulder sonography (time frame: Baseline to 8-10 years follow-up). 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 NCT01829633, which also lists 1 linked publication.
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.