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OpenTrials
Completed

NCT Number: NCT00233922

Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

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.

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Key information

Conditions

Orbital Trauma Craniocerebral Trauma Disease Attributes Facial Injuries Facies Fractures, Bone Maxillofacial Injuries Nervous System Diseases Orbital Fractures Pathologic Processes Pathological Conditions, Signs and Symptoms Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National University Hospital

Singapore, 119074

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Osteosheet(r)

Device

Primary outcomes

  1. visual acuity

  2. Enophthalmos

  3. Diplopia

  4. Cosmetic appearance

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • National Healthcare Group, Singapore

Registry information

Important dates

Study start
2004
Study completion
2007
First posted
Oct 6, 2005
Registry last updated
May 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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