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Elevated Plasma Levels of TIMP-1 in Patients With Rotator Cuff Tear

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanna Bjornsson, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01562145
First received: March 21, 2012
Last updated: March 23, 2012
Last verified: March 2012
History of Changes

March 21, 2012
March 23, 2012
January 2009
February 2010   (final data collection date for primary outcome measure)
Level of MMP and TIMP in plasma [ Time Frame: Measaured at one time point ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01562145 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Elevated Plasma Levels of TIMP-1 in Patients With Rotator Cuff Tear
Elevated Plasma Levels of TIMP-1 in Patients With Rotator Cuff Tear

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.

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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples
Non-Probability Sample

Patients with ultrasound verified rotator cuff tears and healthy age and gender matched controls
Rotator Cuff Tear
Procedure: Blood sampling
Four mL venous blood samples were collected from all study participants after inclusion
  • Patients with rotator cuff tears
    Patients with ultrasound verified rotator cuff tears
    Intervention: Procedure: Blood sampling
  • Healthy controls
    Age and gender matched controls with ultrasound verified intact rotator cuff
    Intervention: Procedure: Blood sampling

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01562145
HannaBjornssonstud3
No
Hanna Bjornsson, University Hospital, Linkoeping
University Hospital, Linkoeping
Not Provided
Principal Investigator: Hanna Björnsson Hallgren, MD University clinic of orthopeadics Linkoeping
University Hospital, Linkoeping
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP