Analysis of Proinflammatory Factors in the Synovial Fluid... | NCT01069224

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

NCT01069224

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Feb 17, 2010Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Rotator Cuff Disease

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Mar 2011Estimated

Completion Date

Mar 2011Estimated

First Submitted Date

Feb 9, 2010

First Submission Date that Met QC Criteria

Feb 16, 2010

First Posted Date

Feb 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2010

Last Update Posted Date

Feb 17, 2010Estimated

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample