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

NCT01069224 | Unknown

• 1 other identifier: MozesG
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Rotator Cuff Disease

Keywords

rotator cuff; synovial fluid; proinflammatory cytokines

Outcome Measures

Primary Outcomes (1)

• cytokines and MMP's levels in patients with RC pathology and in control group

  12 month

Secondary Outcomes (1)

• Levels of pain curve by using Visual Analogue Scale

  12 month

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Revision rotator cuff repair
• Recurrent shoulder surgery
• Psychiatric illness
• Inflammatory condition.
• Current use of anti-inflammatory drugs.
• Previous or current shoulder infection.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Synovial fluid lavages will be collected at the time of arthroscopic RC reconstruction or other shoulder arthroscopy that will be performed for therapeutic goals (instability repair, SLAP lesion).

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 17, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 17, 2010

Record last verified: 2010-02