NCT01562145

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
Last Updated

March 26, 2012

Status Verified

March 1, 2012

Enrollment Period

1.1 years

First QC Date

March 21, 2012

Last Update Submit

March 23, 2012

Conditions

Rotator Cuff Tear

Keywords

Rotator cuff tear, matrix metalloproteinase, tissue inhibitor of matrix metalloproteinase, partial-thickness tear, full-thickness tear, plasma.

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Patients with rotator cuff tears

Patients with ultrasound verified rotator cuff tears

Procedure: Blood sampling

Healthy controls

Age and gender matched controls with ultrasound verified intact rotator cuff

Procedure: Blood sampling

Interventions

Blood samplingPROCEDURE

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

Healthy controlsPatients with rotator cuff tears

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ultrasound verified rotator cuff tears and healthy age and gender matched controls

You may qualify if:

  • \- degenerative rotator cuff tear verified by ultrasound

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University clinic of orthopeadics Linkoeping

Linköping, Östergötland County, 581 85, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 19968600RESULT

  • 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.

    PMID: 15262646RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Hanna Björnsson Hallgren, MD

    University clinic of orthopeadics Linkoeping

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Shoulder surgeon and head of shoulder research team

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 23, 2012

Study Start

January 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

March 26, 2012

Record last verified: 2012-03

Locations

SE(1)