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Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

This study has been completed.
Sponsor:
Collaborator:
National Healthcare Group, Singapore
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00233922
First received: October 5, 2005
Last updated: May 12, 2008
Last verified: May 2008
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, NHG/RPR/04024
Study First Received: October 5, 2005
Last Updated: May 12, 2008
Health Authority: Singapore: Health Sciences Authority

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

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

ClinicalTrials.gov processed this record on November 25, 2014