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Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00233922
First Posted: October 6, 2005
Last Update Posted: May 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Healthcare Group, Singapore
Information provided by:
National University Hospital, Singapore
  Purpose
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 Intervention Phase
Orbital Trauma Orbital Fractures Device: Osteosheet(r) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • visual acuity
  • Enophthalmos
  • Diplopia
  • Cosmetic appearance

Estimated Enrollment: 80
Study Start Date: July 2004
Study Completion Date: July 2007
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233922


Locations
Singapore
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
  More Information

Responsible Party: Thiam-Chye Lim, MBBS, FRCS, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00233922     History of Changes
Other Study ID Numbers: NHG/RPR/04024
First Submitted: October 5, 2005
First Posted: October 6, 2005
Last Update Posted: May 13, 2008
Last Verified: May 2008

Keywords provided by National University Hospital, Singapore:
orbit
orbital
trauma
fractures
facial

Additional relevant MeSH terms:
Orbital Fractures
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures
Fractures, Bone
Wounds and Injuries