Polycaprolactone / Tricalcium Phosphate (PCL/TCP) v Titanium Orbital Implant : Randomised Trial
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 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
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
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Conditions
Fractures
Intervention
Polycaprolactone / Tri-Calcium Phosphate, Titanium Mesh
Location
National University Hospital
Singapore
Singapore
119074
Status
Recruiting
Source
National University Hospital, Singapore
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01119144
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Bone Cements
Adhesives used to fix prosthetic devices to bones and to cement bone to bone in difficult fractures. Synthetic resins are commonly used as cements. A mixture of monocalcium phosphate, monohydrate, alpha-tricalcium phosphate, and calcium carbonate with a sodium phosphate solution is also a useful bone paste.
Titanium
A dark-gray, metallic element of widespread distribution but occurring in small amounts; atomic number, 22; atomic weight, 47.90; symbol, Ti; specific gravity, 4.5; used for fixation of fractures. (Dorland, 28th ed)
Surgical Mesh
Any woven or knit material of open texture used in surgery for the repair, reconstruction, or substitution of tissue. The mesh is usually a synthetic fabric made of various polymers. It is occasionally made of metal.
Femoral Neck Fractures
Fractures of the short, constricted portion of the thigh bone between the femur head and the trochanters. It excludes intertrochanteric fractures which are HIP FRACTURES.
Calcium Carbonate
Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.
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PubMed Articles
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