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

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562145
• Other study ID #: HannaBjornssonstud3
• Status: Completed
• Phase: N/A
• First received: March 21, 2012
• Last updated: March 23, 2012
• Start date: January 2009
• Est. completion date: February 2010

Study information

• Verified date: March 2012
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rotator Cuff Tear

Intervention

Procedure:
• Blood sampling
Four mL venous blood samples were collected from all study participants after inclusion

Locations

Country	Name	City	State
Sweden	University clinic of orthopeadics Linkoeping	Linkoeping	Oestergoetland

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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. Epub 2004 May 18. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of MMP and TIMP in plasma	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.	Measaured at one time point	Yes