NCT00233922

Brief Summary

Patients with orbital injuries are entered into the trial. Age: 20 - 70. After obtaining appropriate consent, they are entered into either a control arm where reconstruction of the orbit is done with a titanium mesh (established practice) or the experimental arm where reconstruction is by a bioresorbable implant made of polycaprolactone. Patients are followuped at 1 week, 1 month, 3 months, 6 months \& 12 months. CT scan of the orbits are performed preop, 6 months \& 12 months. End point is the 12 month follow-up appointment. Visual acuity, range of motion, enophthalmos \& diplopia are assessed in follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

May 13, 2008

Status Verified

May 1, 2008

First QC Date

October 5, 2005

Last Update Submit

May 12, 2008

Conditions

Orbital TraumaOrbital Fractures

Keywords

orbitorbitaltraumafracturesfacial

Outcome Measures

Primary Outcomes (4)

  • visual acuity

  • Enophthalmos

  • Diplopia

  • Cosmetic appearance

Interventions

Osteosheet(r)DEVICE

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age: 20 - 70 years facial trauma with orbital fractures

You may not qualify if:

  • No other coexistent conditions eg. diabetes, heart disease, etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Orbital FracturesWounds and InjuriesFractures, BoneFacies

Condition Hierarchy (Ancestors)

Maxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thiam-Chye Lim, MBBS, FRCS

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 5, 2005

First Posted

October 6, 2005

Study Start

July 1, 2004

Study Completion

July 1, 2007

Last Updated

May 13, 2008

Record last verified: 2008-05

Locations

SG(1)