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Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

NCT00233922 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2008-05-13

No results posted yet for this study

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.

Conditions

  • Orbital Trauma
  • Orbital Fractures

Interventions

DEVICE

Osteosheet(r)

Sponsors & Collaborators

  • National Healthcare Group, Singapore

    collaborator OTHER_GOV

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Thiam-Chye Lim, MBBS, FRCS · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-07-31
Completion
2007-07-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00233922 on ClinicalTrials.gov