Rotator Cuff TearNCT01562145
Elevated Plasma Levels of TIMP-1 in Patients With Rotator Cuff Tear
An observational study of Rotator Cuff Tear, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
The aim of the study was to investigate the levels of matrixmetalloproteinases and their inhibitors in blood samples from patients with rotator cuff tears and compare with blood samples from healthy matched controls. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2009to Feb 2010
- 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: Patients with ultrasound verified rotator cuff tears and healthy age and gender matched controls
Who may be able to join
- degenerative rotator cuff tear verified by ultrasound
Who cannot join
- systemic joint disease such as rheumatoid arthritis
- a fracture non-union
- dupuytrens disease
- frozen shoulder
- tendinosis or rupture of any other tendons than in the rotator cuff
- disorders of the spine such as disc disease,idiopathic scoliosis, spondylitis
Show all 14Show fewer
- cerebral or cardiovascular disease during the past year
- abdominal or bowel disease
- surgery or trauma during the past year
- any infection during the last month
- malignancy
- treatment for the last month with medications that may affect MMPs or TIMPs (tetracycline, bisphosphonates, anti-inflammatory drugs, statins)
- vigorous physical activity during the last 24 hours
- inability to understand written and spoken Swedish
Trial locations and contacts
1 site in 1 country.
Sweden1 site
University clinic of orthopeadics Linkoeping
Linköping, Östergötland County, 581 85
About this study
The aim of the study was to investigate the levels of matrixmetalloproteinases and their inhibitors in blood samples from patients with rotator cuff tears and compare with blood samples from healthy matched controls.
Read the detailed description
Background: Extracellular matrix remodeling is altered in rotator cuff tears, partly due to altered expression of matrix metalloproteinases (MMPs) and their inhibitors. It is unclear if this altered expression can be traced as changes in plasma protein levels. We measured the plasma level of MMPs and their tissue inhibitors (TIMPs) in patients with rotator cuff tears.
Material and methods: Blood samples were collected from 17 patients, median 61 (range 39-77) years, with sonographically verified rotator cuff tears (partial- or full-thickness). These were compared with 16 gender and age matched control persons with sonographically intact rotator cuffs. Plasma levels of MMPs and TIMPs were measured simultaneously using Luminex technology.
- Conditions
- Rotator Cuff Tear
- Being tested
- Blood sampling
- Keywords
- Rotator cuff tear, matrix metalloproteinase, tissue inhibitor of matrix metalloproteinase, partial-thickness tear, full-thickness tear, plasma.
- 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.
Blood samplingProcedure or surgery
Four mL venous blood samples were collected from all study participants after inclusion
| Study group | Role | What they receive |
|---|---|---|
| Patients with rotator cuff tears | Patients with ultrasound verified rotator cuff tears Receives: Procedure: Blood sampling | |
| Healthy controls | Age and gender matched controls with ultrasound verified intact rotator cuff Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of MMP and TIMP in plasma
Four mL venous blood samples were collected from all study participants after inclusion, and centrifuged to plasma that was stored at -70 degrees until the analysis.
Measured: Measaured at one time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startJan 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Bjornsson, University Hospital, Linkoeping
- Investigators
- Hanna Björnsson Hallgren, MD, Principal investigator, University clinic of orthopeadics Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562145
- Sponsor's protocol ID
- HannaBjornssonstud3
- Status last verified
- Mar 2012
- First submitted
- 21 Mar 2012
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pasternak B, Aspenberg P. Metalloproteinases and their inhibitors-diagnostic and therapeutic opportunities in orthopedics. Acta Orthop. 2009 Dec;80(6):693-703. doi: 10.3109/17453670903448257.
PubMed 19968600Lo IK, Marchuk LL, Hollinshead R, Hart DA, Frank CB. Matrix metalloproteinase and tissue inhibitor of matrix metalloproteinase mRNA levels are specifically altered in torn rotator cuff tendons. Am J Sports Med. 2004 Jul-Aug;32(5):1223-9. doi: 10.1177/0363546503262200. Epub 2004 May 18.
PubMed 15262646
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevated Plasma Levels of TIMP-1 in Patients With Rotator Cuff Tear
- ClinicalTrials.gov ID
- NCT01562145
- Acronym / sponsor ID
- HannaBjornssonstud3
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator cuff tear, matrix metalloproteinase, tissue inhibitor of matrix metalloproteinase, partial-thickness tear, full-thickness tear, plasma.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 23 Mar 2012 (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 aim of the study was to investigate the levels of matrixmetalloproteinases and their inhibitors in blood samples from patients with rotator cuff tears and compare with blood samples from healthy matched controls.
Detailed description
Background: Extracellular matrix remodeling is altered in rotator cuff tears, partly due to altered expression of matrix metalloproteinases (MMPs) and their inhibitors. It is unclear if this altered expression can be traced as changes in plasma protein levels. We measured the plasma level of MMPs and their tissue inhibitors (TIMPs) in patients with rotator cuff tears.
Material and methods: Blood samples were collected from 17 patients, median 61 (range 39-77) years, with sonographically verified rotator cuff tears (partial- or full-thickness). These were compared with 16 gender and age matched control persons with sonographically intact rotator cuffs. Plasma levels of MMPs and TIMPs were measured simultaneously using Luminex technology.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with rotator cuff tears | – | Procedure: Blood samplingPatients with ultrasound verified rotator cuff tears |
| Healthy controls | – | Procedure: Blood samplingAge and gender matched controls with ultrasound verified intact rotator cuff |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with ultrasound verified rotator cuff tears and healthy age and gender matched controls
Key inclusion criteria (1 listed)
- degenerative rotator cuff tear verified by ultrasound
Key exclusion criteria (14 listed)
- systemic joint disease such as rheumatoid arthritis
- a fracture non-union
- dupuytrens disease
- frozen shoulder
- tendinosis or rupture of any other tendons than in the rotator cuff
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 |
|---|---|---|
| Blood samplingFour mL venous blood samples were collected from all study participants after inclusion | Procedure or surgery | Healthy controls, Patients with rotator cuff tears |
Primary outcome
Level of MMP and TIMP in plasma
Time frame: Measaured at one time point
Four mL venous blood samples were collected from all study participants after inclusion, and centrifuged to plasma that was stored at -70 degrees until the analysis.
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 26 Mar 2012.
- Results publication: PubMed 19968600Pasternak B, Aspenberg P. Metalloproteinases and their inhibitors-diagnostic and therapeutic opportunities in orthopedics. Acta Orthop. 2009 Dec;80(6):693-703. doi: 10.3109/17453670903448257.
- Results publication: PubMed 15262646Lo IK, Marchuk LL, Hollinshead R, Hart DA, Frank CB. Matrix metalloproteinase and tissue inhibitor of matrix metalloproteinase mRNA levels are specifically altered in torn rotator cuff tendons. Am J Sports Med. 2004 Jul-Aug;32(5):1223-9. doi: 10.1177/0363546503262200. Epub 2004 May 18.
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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.
Hanna Björnsson Hallgren, MD principal investigator
University clinic of orthopeadics Linkoeping
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 University Hospital, Linkoeping at 1 site in Sweden.
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 14 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 26 Mar 2012. 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 Sweden. 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?
Level of MMP and TIMP in plasma (time frame: Measaured at one time point). 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 NCT01562145, which also lists 2 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 26 Mar 2012.