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

This study is currently recruiting participants.
Verified July 2010 by National University Hospital, Singapore
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01119144
First received: May 5, 2010
Last updated: July 1, 2010
Last verified: July 2010
History of Changes
  Purpose

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 2013

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

Condition Intervention Phase
Fractures
Enophthalmos
Diplopia
 Device: Polycaprolactone / Tri-Calcium Phosphate
Device: Titanium Mesh
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparing the Reconstruction of the Orbit Fracture With a Poly Caprolactone / Tri-Calcium Phosphate ( PCL/TCP ) Implant vs. a Titanium Mesh Implant

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Enophthalmos [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assess the presence of enophthalmos after reconstruction of the orbital walls at 1 week, 1 month, 3 months, 6 months and 12 months


Secondary Outcome Measures:
  • Diplopia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assess the evidence of diplopia on follow up at 1 week, 1 month, 3 months, 6 months and 12 months

  • motility of the globe [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    assess globe motility on follow up at 1 week, 1 month, 3 months, 6 months, and 12 months


Estimated Enrollment: 80
Study Start Date: April 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Polycaprolactone / Tricalcium Phosphate
Polycaprolactone / Tricalcium Phosphate group to assess efficacy of new implant
 Device: Polycaprolactone / Tri-Calcium Phosphate
Orbital implant for reconstruction of the orbital walls
Other Name: Osteomesh Tri-Calcium Phosphate (TCP)
Active Comparator: Control
Control group with titanium mesh
 Device: Titanium Mesh
Titanium mesh for comparison to Polycaprolactone / Tri-Calcium Phosphate (PCL / TCP) mesh
Other Name: Titanium Orbital mesh

Detailed Description:

Hypothesis: Polycaprolactone / Tricalcium Phosphate (PCL / TCP) Orbital Implant is as effective in the reconstruction of the Orbital walls as Titanium Mesh

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 confirmed by Computer Tomographic (CT) scans, 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 2013

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
  • all patients will be seen & assessed in the Plastic & Ophthalmology outpatient clinics by Principal Investigator (PI) and collaborators

End point :

  • endpoint for follow-up is 12 months
  • all patients are assessed for assessed for diplopia, enophthalmos, exophthalmos, visual acuity, mobility of the globe, contour symmetry
  • all patients will have a Computer Tomographic (CT) scan of the orbits at 12 months to assess the bony orbit & orbital volume
  • patients will be discharged from follow up at 12 months if asymptomatic
  • patients with complications will exit the protocol & will be treated on their merits eg. infection - removal of implant, etc

Data Management :

  • maintained by the Principal Investigator (PI) under repository of the Research & Development Office, National Healthcare Group (NHG) / National University Health Systems (NUHS), Singapore
  • no data will be released without the permission of the Principal Investigator (PI) & the Research & Development Office, National Healthcare Group (NHG) / National University Health Systems (NUHS), Singapore
  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patient refusal
  • infection around the orbit / generalised infection
  • Diabetes mellitus
  • allergies to polycaprolactone & its analogues
  • allergies to titanium
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119144

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Thiam Chye Lim         surlimtc@nus.edu.sg    
Contact: Eileen Hing         surhch@nus.edu.sg    
Principal Investigator: Thiam Chye Lim, FRCS            
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Thiam Chye Lim, MD Natioanl University Hospital, Singapore
  More Information

No publications provided

Responsible Party: LIM THIAM CHYE / Professor, National University Hospital / National Unviersity of Singapore
ClinicalTrials.gov Identifier: NCT01119144     History of Changes
Other Study ID Numbers: NUHS/SUR/2010/1, D / 08 / 465
Study First Received: May 5, 2010
Last Updated: July 1, 2010
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
Orbital
fractures
enophthalmos
diplopia
eye

Additional relevant MeSH terms:
Diplopia
Enophthalmos
Fractures, Bone
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
 Signs and Symptoms
Orbital Diseases
Wounds and Injuries
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013