FracturesPhase 2PCL/TCPNCT01119144
Polycaprolactone / Tricalcium Phosphate (PCL/TCP) v Titanium Orbital Implant : Randomised Trial
A Phase 2 study testing Polycaprolactone / Tri-Calcium Phosphate and Titanium Mesh in people with Fractures and Enophthalmos, run by National University Hospital, Singapore at 1 site in Singapore.
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… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Fractures, Enophthalmos, Diplopia
- What is being tested?
- Polycaprolactone / Tri-Calcium Phosphate and Titanium Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2010to Mar 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 21 y - 70 y
- both males / females included
- orbital fractures
- defect after orbital osteotomies
Who cannot join
- patient refusal
- infection around the orbit / generalised infection
- Diabetes mellitus
- allergies to polycaprolactone \& its analogues
- allergies to titanium
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, Singapore, 119074
Thiam Chye Lim, surlimtc@nus.edu.sg
Eileen Hing, surhch@nus.edu.sg
About this study
Official title: Comparing the Reconstruction of the Orbit Fracture With a Poly Caprolactone / Tri-Calcium Phosphate ( PCL/TCP ) Implant vs. a Titanium Mesh Implant.
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
Read more
- 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
Read the 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 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
- 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
- Conditions
- Fractures, Enophthalmos, Diplopia
- Being tested
- Polycaprolactone / Tri-Calcium Phosphate, Titanium Mesh
- Keywords
- Orbital, fractures, enophthalmos, diplopia, eye
- Medical subject headings
- Fractures, Bone, Enophthalmos, Diplopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polycaprolactone / Tri-Calcium PhosphateDevice
Also called Osteomesh Tri-Calcium Phosphate (TCP)
Orbital implant for reconstruction of the orbital walls
Titanium MeshDevice
Also called Titanium Orbital mesh
Titanium mesh for comparison to Polycaprolactone / Tri-Calcium Phosphate (PCL / TCP) mesh
| Study group | Role | What they receive |
|---|---|---|
| Polycaprolactone / Tricalcium Phosphate | Experimental | Polycaprolactone / Tricalcium Phosphate group to assess efficacy of new implant Receives: Device: Polycaprolactone / Tri-Calcium Phosphate |
| Control | Active comparator | Control group with titanium mesh Receives: Device: Titanium Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enophthalmos
Assess the presence of enophthalmos after reconstruction of the orbital walls at 1 week, 1 month, 3 months, 6 months and 12 months
Measured: 1 year
Secondary outcomes (2)
Diplopia
Assess the evidence of diplopia on follow up at 1 week, 1 month, 3 months, 6 months and 12 months
Measured: 1 year
motility of the globe
assess globe motility on follow up at 1 week, 1 month, 3 months, 6 months, and 12 months
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FracturesStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Thiam Chye Lim, MD, Principal investigator, Natioanl University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119144
- Sponsor's protocol ID
- NUHS/SUR/2010/1
- Other IDs
- D / 08 / 465
- Acronym
- PCL/TCP
- Status last verified
- Apr 2014
- First submitted
- 5 May 2010
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Reconstruction of the Orbit Fracture With a Poly Caprolactone / Tri-Calcium Phosphate ( PCL/TCP ) Implant vs. a Titanium Mesh Implant.
- ClinicalTrials.gov ID
- NCT01119144
- Acronym / sponsor ID
- PCL/TCP / NUHS/SUR/2010/1
- Conditions
- Fractures, Enophthalmos, Diplopia
- Keywords
- Orbital, fractures, enophthalmos, diplopia, eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 7 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polycaprolactone / Tricalcium Phosphate | Experimental | Device: Polycaprolactone / Tri-Calcium PhosphatePolycaprolactone / Tricalcium Phosphate group to assess efficacy of new implant |
| Control | Active comparator | Device: Titanium MeshControl group with titanium mesh |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 21 y - 70 y
- both males / females included
- orbital fractures
- defect after orbital osteotomies
Key exclusion criteria (5 listed)
- patient refusal
- infection around the orbit / generalised infection
- Diabetes mellitus
- allergies to polycaprolactone \& its analogues
- allergies to titanium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polycaprolactone / Tri-Calcium PhosphateAlso: Osteomesh Tri-Calcium Phosphate (TCP)Orbital implant for reconstruction of the orbital walls | Device | Polycaprolactone / Tricalcium Phosphate |
| Titanium MeshAlso: Titanium Orbital meshTitanium mesh for comparison to Polycaprolactone / Tri-Calcium Phosphate (PCL / TCP) mesh | Device | Control |
Primary outcome
Enophthalmos
Time frame: 1 year
Assess the presence of enophthalmos after reconstruction of the orbital walls at 1 week, 1 month, 3 months, 6 months and 12 months
2 secondary outcomes
Diplopia
Time frame: 1 year
motility of the globe
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thiam Chye Lim, MD principal investigator
Natioanl University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polycaprolactone / Tri-Calcium Phosphate and Titanium Mesh in people with Fractures and Enophthalmos, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enophthalmos (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2014.