Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

• Sponsor: National University Hospital, Singapore (Other)
• Overall Status: Completed
• CT.gov ID: NCT00233922
• Collaborator: National Healthcare Group, Singapore (Other)
• Enrollment: 80
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 2.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Orbital Trauma; Orbital Fractures	Device: Osteosheet(r)	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant
• Study Start Date: Jul 1, 2004
• Actual Study Completion Date: Jul 1, 2007

Outcome Measures

Primary Outcome Measures

1. visual acuity []

2. Enophthalmos []

3. Diplopia []

4. Cosmetic appearance []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National University Hospital	Singapore		Singapore	119074

Sponsors and Collaborators

• National University Hospital, Singapore
• National Healthcare Group, Singapore

Investigators

• Principal Investigator: Thiam-Chye Lim, MBBS, FRCS, National University Hospital, Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00233922
• Other Study ID Numbers: NHG/RPR/04024; NHG/RPR/04024
• First Posted: Oct 6, 2005
• Last Update Posted: May 13, 2008
• Last Verified: May 1, 2008

• Keywords provided by , ,: orbit; orbital; trauma; fractures; facial
• Additional relevant MeSH terms: Orbital Fractures

Study Results

No Results Posted as of May 13, 2008