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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01069224
First received: February 9, 2010
Last updated: February 16, 2010
Last verified: February 2010
  Purpose

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.


Condition
Rotator Cuff Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • cytokines and MMP's levels in patients with RC pathology and in control group [ Time Frame: 12 month ]

Secondary Outcome Measures:
  • Levels of pain curve by using Visual Analogue Scale [ Time Frame: 12 month ]

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).

Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Maman Eran MD, Tel Aviv Medical Center
ClinicalTrials.gov Identifier: NCT01069224     History of Changes
Other Study ID Numbers: MozesG
Study First Received: February 9, 2010
Last Updated: February 16, 2010

Keywords provided by Tel-Aviv Sourasky Medical Center:
rotator cuff
synovial fluid
proinflammatory cytokines

ClinicalTrials.gov processed this record on July 28, 2017