Arthroscopic Guided Synovial Biopsies | NCT03279016

Studies
Arthroscopic Guided Synovial Biopsies

NCT03279016

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Feb 6, 2018Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Temporomandibular Arthritis

Interventions

Not provided

Countries

Egypt

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 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2018Estimated

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Aug 31, 2017

First Submission Date that Met QC Criteria

Sep 8, 2017

First Posted Date

Sep 12, 2017Actual

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 4, 2018

Last Update Posted Date

Feb 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To detect accuracy of serology in diagnosis of temporomandibular joint arthritis.

Detailed Description

According to a search of previously published studies on accuracy of serology no sensitivity or specificity data was found regarding accurate detection of arthritis through serology, hence the aim of this study is to detect accuracy of serology in diagnosis of temporomandibular joint arthritis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
accuracy of serology	To determine the sensitivity or specificity of serology in diagnosis of temporomandibular joint arthritis	2 years

Secondary Outcomes

Measure	Description	Time Frame
Rheumatoid factor	To be measured in a blood sample with (IU/mL) unit as The normal reference range for RF is less than 15 IU/mL	2 years
C-reactive protein	To be measured in a blood sample with (mg/dL) unit where Normal CRP levels are below 3.0 mg/dL.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients suffering from TEMPOROMANDIBULAR JOINT ARTHRITIS.
Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
Patients who will agree to the consent

Exclusion Criteria:

Patients with any systemic disease that may affect normal healing.
Pregnant females.
Patients with acute infection.
Patients with bony ankyloses.
Patients with risk of tumor dissemination.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patient complaing from arthritis symptoms,an diagnosed as arthritic patient with MRI

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
AHMED EISSA, MASTER	Contact	+201147700383		drahmedadel75@gmail.com

Overall Officials

Name	Affiliation	Role
sameh mekhaimer, professor	professor of oral and maxillofacial surgery,faculty of oral and dental medicine,Cairo university	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Oral and Dental Medicine	Completed	Cairo			Egypt
Faculty of Oral and Dental Medicine

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided