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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01562145
First Posted: March 23, 2012
Last Update Posted: March 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hanna Bjornsson, University Hospital, Linkoeping
  Purpose
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.

Condition Intervention
Rotator Cuff Tear Procedure: Blood sampling

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Elevated Plasma Levels of TIMP-1 in Patients With Rotator Cuff Tear

Resource links provided by NLM:


Further study details as provided by Hanna Bjornsson, University Hospital, Linkoeping:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA
Blood samples

Enrollment: 34
Study Start Date: January 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with rotator cuff tears
Patients with ultrasound verified rotator cuff tears
Procedure: Blood sampling
Four mL venous blood samples were collected from all study participants after inclusion
Healthy controls
Age and gender matched controls with ultrasound verified intact rotator cuff
Procedure: Blood sampling
Four mL venous blood samples were collected from all study participants after inclusion

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with ultrasound verified rotator cuff tears and healthy age and gender matched controls
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562145


Locations
Sweden
University clinic of orthopeadics Linkoeping
Linkoeping, Oestergoetland, Sweden, 581 85
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
Principal Investigator: Hanna Björnsson Hallgren, MD University clinic of orthopeadics Linkoeping
  More Information

Publications:
Responsible Party: Hanna Bjornsson, MD, Shoulder surgeon and head of shoulder research team, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01562145     History of Changes
Other Study ID Numbers: HannaBjornssonstud3
First Submitted: March 21, 2012
First Posted: March 23, 2012
Last Update Posted: March 26, 2012
Last Verified: March 2012

Keywords provided by Hanna Bjornsson, University Hospital, Linkoeping:
Rotator cuff tear, matrix metalloproteinase, tissue inhibitor of matrix metalloproteinase, partial-thickness tear, full-thickness tear, plasma.

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries