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Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

NCT ID: NCT00233922

Last Updated: 2008-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-07-31

Brief Summary

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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

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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.

Conditions

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Orbital Trauma Orbital Fractures

Keywords

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orbit orbital trauma fractures facial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Osteosheet(r)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No other coexistent conditions eg. diabetes, heart disease, etc
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Healthcare Group, Singapore

OTHER_GOV

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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National University Hospital, Singapore

Principal Investigators

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Thiam-Chye Lim, MBBS, FRCS

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

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National University Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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NHG/RPR/04024

Identifier Type: -

Identifier Source: secondary_id

NHG/RPR/04024

Identifier Type: -

Identifier Source: org_study_id