Clinical trial NCT01562145: Elevated Plasma Levels of TIMP-1 in Patients With Rotator Cuff Tear
Official title: Elevated Plasma Levels of TIMP-1 in Patients With Rotator Cuff Tear
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Keywords: Rotator cuff tear, matrix metalloproteinase, tissue inhibitor of matrix metalloproteinase, partial-thickness tear, full-thickness tear, plasma.
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2012-03-23
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ultrasound verified rotator cuff tears and healthy age and gender matched controls

Brief summary: 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: 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 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

Primary outcomes:
measure: Level of MMP and TIMP in plasma
timeFrame: Measaured at one time point
Secondary outcomes:
Other outcomes:
Locations:
city: Linkoeping
country: Sweden
facility: University clinic of orthopeadics Linkoeping
state: Oestergoetland
Study officials:
affiliation: University clinic of orthopeadics Linkoeping
name: Hanna Björnsson Hallgren, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.