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

NCT ID: NCT01562145

Last Updated: 2012-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-02-28

Brief Summary

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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

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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

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Rotator Cuff Tear

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with rotator cuff tears

Patients with ultrasound verified rotator cuff tears

Blood sampling

Intervention Type PROCEDURE

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

Blood sampling

Intervention Type PROCEDURE

Four mL venous blood samples were collected from all study participants after inclusion

Interventions

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Blood sampling

Four mL venous blood samples were collected from all study participants after inclusion

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

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Hanna Bjornsson

MD, Shoulder surgeon and head of shoulder research team

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hanna Björnsson Hallgren, MD

Role: PRINCIPAL_INVESTIGATOR

University clinic of orthopeadics Linkoeping

Locations

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University clinic of orthopeadics Linkoeping

Linköping, Östergötland County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type RESULT
PMID: 19968600 (View on PubMed)

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.

Reference Type RESULT
PMID: 15262646 (View on PubMed)

Other Identifiers

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HannaBjornssonstud3

Identifier Type: -

Identifier Source: org_study_id

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