Analysis of Proinflammatory Factors in the Synovial Fluid In Patients With Rotator Cuff Disease

NCT ID: NCT01069224

Last Updated: 2010-02-17

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

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-03-31

Brief Summary

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Role of proinflammatory factors in Patients with Rotator Cuff Disease

Objective:

To measure the levels of various cytokines and metalloproteases in patients with rotator cuff disease, and control group and to determine the correlations among them.

Detailed Description

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We hypothesize that cytokines and MMP's level will be significantly higher in patients with RC pathology than in control group and will be related to the time frame since injury (i.e. - higher levels as close to the injury). In addition we will examine possible relation of those levels to the pain curve by using Visual Analogue Scale.

Conditions

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Rotator Cuff Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RC tear

This study will include a consecutive series of patients who met the study inclusion criteria. Study group patients will be diagnosed RC tear on clinical examination and imaging findings (US and MRI) that will be verified at arthroscopy in order to complete the enrollment.

No interventions assigned to this group

Control group

Control group will include patients suffering from shoulder instability that scheduled for elective surgical repair.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation.
2. Patients between age 18-65 scheduled for a surgery in a Shoulder unit
3. Patients suffering from Rotator Cuff Disease
4. Patients suffering from any noninflammatory shoulder condition which requires surgical intervention

Exclusion Criteria

1. Revision rotator cuff repair
2. Recurrent shoulder surgery
3. Psychiatric illness
4. Inflammatory condition.
5. Current use of anti-inflammatory drugs.
6. Previous or current shoulder infection.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tel Aviv Medical Center

Other Identifiers

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MozesG

Identifier Type: -

Identifier Source: org_study_id

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