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

Rotator Cuff Disease Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01069224
• Other study ID #: MozesG
• Status: Not yet recruiting
• Phase: N/A
• First received: February 9, 2010
• Last updated: February 16, 2010
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: February 2010
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rotator Cuff Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cytokines and MMP's levels in patients with RC pathology and in control group		12 month	No
Secondary	Levels of pain curve by using Visual Analogue Scale		12 month	No