- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01562145
Elevated Plasma Levels of TIMP-1 in Patients With Rotator Cuff Tear
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oestergoetland
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Linkoeping, Oestergoetland, Sweden, 581 85
- University clinic of orthopeadics Linkoeping
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- degenerative rotator cuff tear verified by ultrasound
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with rotator cuff tears
Patients with ultrasound verified rotator cuff tears
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Four mL venous blood samples were collected from all study participants after inclusion
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Healthy controls
Age and gender matched controls with ultrasound verified intact rotator cuff
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Four mL venous blood samples were collected from all study participants after inclusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of MMP and TIMP in plasma
Time Frame: Measaured at one time point
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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.
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Measaured at one time point
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hanna Björnsson Hallgren, MD, University clinic of orthopeadics Linkoeping
Publications and helpful links
General 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.
- Lo 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HannaBjornssonstud3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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