Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

Orbital Fractures Clinical Trial

Official title:

Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233922
• Other study ID #: NHG/RPR/04024
• Secondary ID: NHG/RPR/04024
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2005
• Last updated: May 12, 2008
• Start date: July 2004
• Est. completion date: July 2007

Study information

• Verified date: May 2008
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Orbital Fractures
• Orbital Trauma

Intervention

Device:
• Osteosheet(r)

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National Healthcare Group, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity
Primary	Enophthalmos
Primary	Diplopia
Primary	Cosmetic appearance