Prosthetic Motility and Complications in Pegged Versus Un... | NCT00371280

Studies
Prosthetic Motility and Complications in Pegged Versus Unpegged Hydroxyapatite Orbital Implants

NCT00371280

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Unknown status

Last Update Posted

May 12, 2010Estimated

Enrollment

50Estimated

Phase

Phase 2Phase 3

Conditions

Anophthalmos
Orbital Implants

Interventions

orbital implant

Countries

Iran

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

Jun 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Oct 2006Estimated

Completion Date

Nov 2006Estimated

First Submitted Date

Sep 1, 2006

First Submission Date that Met QC Criteria

Sep 1, 2006

First Posted Date

Sep 4, 2006Estimated

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

May 10, 2010

Last Update Posted Date

May 12, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Pegging the hydroxyapatite for increasing prosthetic motility sometimes leads to some complications for the patient. These complications ranging from discharge, granuloma formation, exposure, implant infection to socket discomfort and etc. We are going to compare prosthetic motility, objectively and subjectively (patients satisfaction) before and after pegging the hydroxy- apatite, and evaluate the complications after pegging.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Pegged unpegged hydroxyapatite orbital implantation	Procedure: orbital implant
2	Active Comparator	Unpegged hydroxyapatite orbital implantation	Procedure: orbital implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
orbital implant	Procedure	Implantation of pegged versus unpegged hydroxyapatite orbital implants	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changing movement in up gaze: 0.58 mm
Changing movement in down gaze: 0.83 mm
Changing movement in medial gaze: 0.75 mm
Changing movement in lateral gaze: 1.2 mm

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

orbital hydroxyapatite implants

Exclusion Criteria:

history of systemic disease
history of radio therapy
secondary hydroxapatite implant
complications lead to re-surgery

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Babak Babsharif, MD	Ophthalmic Research Center of Shaheed Beheshti Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Babak Babsharif, MD		Tehran	Tehran Province	16666	Iran

Condition Browse Module

MeSH Terms

ID	Term
D000853	Anophthalmos

Ancestor Terms

ID	Term
D005124	Eye Abnormalities
D005128	Eye Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020273	Orbital Implants

Ancestor Terms

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided