Analysis of Proinflammatory Factors in the Synovial Fluid In Patients With Rotator Cuff Disease
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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 |
- cytokines and MMP's levels in patients with RC pathology and in control group [ Time Frame: 12 month ] [ Designated as safety issue: No ]
- Levels of pain curve by using Visual Analogue Scale [ Time Frame: 12 month ] [ Designated as safety issue: No ]
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.
|
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Control group
Control group will include patients suffering from shoulder instability that scheduled for elective surgical repair.
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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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Revision rotator cuff repair
- Recurrent shoulder surgery
- Psychiatric illness
- Inflammatory condition.
- Current use of anti-inflammatory drugs.
- Previous or current shoulder infection.
Contacts and Locations More Information
No publications provided
| 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 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
rotator cuff synovial fluid proinflammatory cytokines |
ClinicalTrials.gov processed this record on May 16, 2013