Polycaprolactone / Tricalcium Phosphate (PCL/TCP) v Titanium Orbital Implant : Randomised Trial

NCT01119144 | Unknown Phase 2 DMC

• 2 other identifiers: NUHS/SUR/2010/1D / 08 / 465
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: Polycaprolactone / Tricalcium Phosphate Orbital (PCL / TCP) Implant is as effective in the reconstruction of the Orbital walls as Titanium Mesh implant. In this study we will be conducting a randomised trial to compare implants made of 2 materials for Orbital reconstruction

• Polycaprolactone / Tricalcium Phosphate (PCL / TCP)
• Titanium Patients to be recruited :
• 80 randomised equally into the 2 groups
• age range: 21 - 70
• includes orbital wall defects from trauma, after osteotomies
• excludes patients with Diabetes Mellitus, known allergies to polycaprolactone \& its analogues, know allergies to Tricalcium Phosphate \& its analogues, infections generalised \& around the orbital region Trial Duration: April 2010 - March 2015 Follow up:
• postoperative 1 week, 1 month, 3 months, 6 months, and 12 months
• Computer Tomographic (CT) scan of Orbits immediate postoperative and at 12 months appointment

Conditions

Fractures; Enophthalmos; Diplopia

Keywords

Orbital; fractures; enophthalmos; diplopia; eye

Outcome Measures

Primary Outcomes (1)

• Enophthalmos

  Assess the presence of enophthalmos after reconstruction of the orbital walls at 1 week, 1 month, 3 months, 6 months and 12 months

  1 year

Secondary Outcomes (2)

• Diplopia

  1 year

• motility of the globe

  1 year

Study Arms (2)

Polycaprolactone / Tricalcium Phosphate

EXPERIMENTAL

Polycaprolactone / Tricalcium Phosphate group to assess efficacy of new implant

Device: Polycaprolactone / Tri-Calcium Phosphate

Control

ACTIVE COMPARATOR

Control group with titanium mesh

Device: Titanium Mesh

Interventions

Polycaprolactone / Tri-Calcium Phosphate DEVICE

Orbital implant for reconstruction of the orbital walls

Also known as: Osteomesh Tri-Calcium Phosphate (TCP)

Polycaprolactone / Tricalcium Phosphate

Titanium Mesh DEVICE

Titanium mesh for comparison to Polycaprolactone / Tri-Calcium Phosphate (PCL / TCP) mesh

Also known as: Titanium Orbital mesh

Control

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 21 y - 70 y
• both males / females included
• orbital fractures
• defect after orbital osteotomies

You may not qualify if:

• patient refusal
• infection around the orbit / generalised infection
• Diabetes mellitus
• allergies to polycaprolactone \& its analogues
• allergies to titanium

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

RECRUITING

MeSH Terms

Conditions

Fractures, Bone; Enophthalmos; Diplopia

Condition Hierarchy (Ancestors)

Wounds and Injuries; Orbital Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thiam Chye Lim, MD

  Natioanl University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 7, 2010
• Study Start: April 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

SG (1)