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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
  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

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • 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.


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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: March 21, 2012
Last Updated: March 23, 2012
Health Authority: Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Lacerations
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013