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

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.

Study Overview

• Status: Unknown
• Conditions: Rotator Cuff Disease

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cytokines and MMP's levels in patients with RC pathology and in control group	12 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Levels of pain curve by using Visual Analogue Scale	12 month

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): March 1, 2011
• Study Completion (Anticipated): March 1, 2011

Study Registration Dates

• First Submitted: February 9, 2010
• First Submitted That Met QC Criteria: February 16, 2010
• First Posted (Estimate): February 17, 2010

Study Record Updates

• Last Update Posted (Estimate): February 17, 2010
• Last Update Submitted That Met QC Criteria: February 16, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: proinflammatory cytokines; synovial fluid; rotator cuff
• Other Study ID Numbers: MozesG