Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

Official Title ^†

Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence Study

Primary Outcome Measure ^†

visual acuity
Enophthalmos
Diplopia
Cosmetic appearance

Secondary Outcome Measure ^†

Condition ^†

Orbital Trauma
Orbital Fractures

Intervention ^†

Device: Osteosheet(r)

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

July 2004

Completion Date

July 2007

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

age: 20 - 70 years facial trauma with orbital fractures

Exclusion Criteria:

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

Gender

Both

Ages

20 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Singapore

Administrative Information Fields

NCT ID ^†

NCT00233922

Organization ID

NHG/RPR/04024

Secondary IDs ^††

NHG/RPR/04024

Study Sponsor ^†

National University Hospital, Singapore

Collaborators ^††

National Healthcare Group, Singapore

Investigators ^†

Principal Investigator:

Thiam-Chye Lim, MBBS, FRCS

National University Hospital, Singapore

Information Provided By

National University Hospital, Singapore

Verification Date

May 2008

First Received Date ^†

October 5, 2005

Last Updated Date

May 12, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.