Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Singapore

Study Type

Interventional

Intervention

Osteosheet(r)

About this trial

This is an interventional treatment trial for Orbital Trauma focused on measuring orbit, orbital, trauma, fractures, facial

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: age: 20 - 70 years facial trauma with orbital fractures Exclusion Criteria: No other coexistent conditions eg. diabetes, heart disease, etc

Sites / Locations

National University Hospital

Outcomes

Primary Outcome Measures

visual acuity

Enophthalmos

Diplopia

Cosmetic appearance

Secondary Outcome Measures

Full Information

NCT ID

NCT00233922

First Posted

October 5, 2005

Last Updated

May 12, 2008

Sponsor

National University Hospital, Singapore

Collaborators

National Healthcare Group, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT00233922

Brief Title

Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

Official Title

Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

National University Hospital, Singapore

Collaborators

National Healthcare Group, Singapore

4. Oversight

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Orbital Trauma, Orbital Fractures

Keywords

orbit, orbital, trauma, fractures, facial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Osteosheet(r)

Primary Outcome Measure Information:

Title

visual acuity

Title

Enophthalmos

Title

Diplopia

Title

Cosmetic appearance

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age: 20 - 70 years facial trauma with orbital fractures Exclusion Criteria: No other coexistent conditions eg. diabetes, heart disease, etc

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thiam-Chye Lim, MBBS, FRCS

Organizational Affiliation

National University Hospital, Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

National University Hospital

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Orbital Trauma, Orbital Fractures

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial