Significant Bone Defect in the OrbitTOR-3DNCT03608280
Efficiency of 3D-printed Implant Versus Autograft for Orbital Reconstruction (TOR-3D)
A study testing Bone autograft and Orbital reconstruction by 3D-printed porous titanium implant in people with Significant Bone Defect in the Orbit, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Two scenarios may result in significant bone defect in the orbit: surgical oncology (meningioma, cancers of the upper aerodigestive tract) or severe trauma. This defect in the bone substance may affect the orbital floor, medial wall or lateral wall. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Significant Bone Defect in the Orbit
- What is being tested?
- Bone autograft and Orbital reconstruction by 3D-printed porous titanium implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2023to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient between 18 to 90 years old
- Presenting a defect in the bone substance of an orbital wall (floor, lateral or medial): at least 6 months following a oncologic surgery (in particular meningioma or carcinoma of the upper aerodigestive tract) OR post-traumatic;
- With a defect of the unilateral orbital bone substance described as complex on the CT-scan: fracture in the posterior third of one walls; fracture extended to two walls (floor and lateral wall, or medial wall and orbital floor); comminutive fracture of at least one of the walls; fracture with more than half of one of the walls tipped over;
- Presenting an enophthalmos ≥ 3 mm OR an enophthalmos ≥ 2mm with diplopia;
- Patient with a programmed orbital reconstruction;
- For patients who have had oncologic surgery, validation of a multidisciplinary consultation meeting;
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- Whose contralateral orbital anatomy is healthy (absence of : bone defect, diplopia, ptosis or other condition affecting aesthetics);
- Patient who gave its written informed consent to participate to the study;
- Affiliated to a social insurgence regime or similar.
Who cannot join
- Defect of bone substance extended to the upper and / or intermediate floors of the skull-base;
- For patients who have undergone oncologic surgery, patients with uncontrolled cancer proliferation;
- Defect of bone substance from the skull vault;
- Osteo-meningeal Breach;
- Patient whose understand the French questionnaire EQ-5D-3L;
- Follow up not possible during 18months (judgement of investigator)
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- Patient with hypersensitivity to metallic materials;
- Major patient protected by the Law;
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon, Groupement Hospitalier Sud Chirurgie maxillo-faciale
Pierre-Bénite, 69495
Pierre BOULETREAU, Pr, 04 78 86 19 36, pierre.bouletreau@chu-lyon.fr
Pierre BOULETREAU, Pr
About this study
Official title: Evaluation of the Efficiency for Orbital Reconstruction After Defect of Bone Substance by Three-dimensional Printed Patient Specific Porous Titanium Implant in Comparison With Autologous Bone Graft
Two scenarios may result in significant bone defect in the orbit: surgical oncology (meningioma, cancers of the upper aerodigestive tract) or severe trauma. This defect in the bone substance may affect the orbital floor, medial wall or lateral wall. These injuries can result in functional complications such as enophthalmos and diplopia, and an esthetic impact affecting the quality of life. The most frequent complication in orbital traumas is enophthalmos (10-20% according to publications).
The aim of bone substance reconstruction is to restore the volume and the internal shape of the orbit. The gold standard is autologous bone grafts. The surgery which usually lasts 2 to 3 hours depending on the number of walls involved, can lead to ophthalmological or esthetic complications. Its results are unsatisfactory, and the use of titanium implants would allow a reconstruction of the orbital volume more optimal than the autograft.
Read more
The development of computer-assisted techniques permitted implants evolution: initially peri-operatively preformed, today patient specific implant can be obtained from data of CT-scan. In cranioplasties, a randomized study showed better results at 12 months of these implants compared to the autograft. Their success rate is close to 100% with less than 5% of postoperative complication, while the rate used for cortical graft reconstructions is 20-25%.
Today, 3D printing of patient-specific porous titanium implants is possible. A study has shown that they allow a more accurate reconstruction compared to preformed implants. This innovation is available in France but it has a high cost (2,000 euros on average) and is currently not refunded. However, the use of this technology would reduce the operating time and the morbidity per- and post-operative, with functional and esthetic results superior to those obtained with bone autograft.
- Conditions
- Significant Bone Defect in the Orbit
- Being tested
- Bone autograft, Orbital reconstruction by 3D-printed porous titanium implant
- Keywords
- orbital reconstruction, 3D-printed patient specific porous titanium implant, autologous bone graft, medico-economic study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone autograftProcedure or surgery
The principle of this surgery is based on the removal of a portion of the outer bone layer from the vault of the skull in order to have a flat and solid bone element (cortical bone), which can be carved freehand to better replace the defective bone wall.
Orbital reconstruction by 3D-printed porous titanium implantProcedure or surgery
From data of a patient's CT-scan, it is possible to perform a "mirroring". The unaffected orbit is mirrored onto the affected orbit, via a virtual treatment planning, in order to rely on facial symmetry to virtually restore healthy anatomy. From this simulation, the implant is 3D-printed by Selective Laser Melted (SLM) technique using titanium powder. This technique enabling the creation of custom-made implants is called computer-aided design and computer-aided manufacturing (CAD-CAM).
After sterilization, the implant is ready to be placed during a surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Autograft | Active comparator | Reconstructive surgery by autologous bone graft (bone autograft). It is the gold standard strategy. Receives: Procedure: Bone autograft |
| 3D implant | Experimental | Orbital reconstruction by 3D-printed porous titanium implant (PorousiTi®, laboratoire OBL/MATERIALISE).
The device is a custom-made porous titanium implant processed by selective laser melting (SLM technique) Receives: Procedure: Orbital reconstruction by 3D-printed porous titanium implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental cost per quality-adjusted life-years (QALY) gained
QALY will be measured by EQ-5D-3L questionnaire. At 18 months post reconstruction, we can estimate most of the costs of surgery and its consequences.
Incremental cost per quality-adjusted life-years (QALY) gained between patients with 3D-printed patient specific porous titanium implant or autologous bone graft for orbital reconstruction.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start4 May 2023
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Significant Bone Defect in the OrbitStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608280
- Sponsor's protocol ID
- 69HCL18_0049
- Other IDs
- 2019-A02556-51
- Acronym
- TOR-3D
- Status last verified
- May 2023
- First submitted
- 24 Jul 2018
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency for Orbital Reconstruction After Defect of Bone Substance by Three-dimensional Printed Patient Specific Porous Titanium Implant in Comparison With Autologous Bone Graft
- ClinicalTrials.gov ID
- NCT03608280
- Acronym / sponsor ID
- TOR-3D / 69HCL18_0049
- Conditions
- Significant Bone Defect in the Orbit
- Keywords
- orbital reconstruction, 3D-printed patient specific porous titanium implant, autologous bone graft, medico-economic study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 31 Jul 2018 (actual)
- 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.
Two scenarios may result in significant bone defect in the orbit: surgical oncology (meningioma, cancers of the upper aerodigestive tract) or severe trauma. This defect in the bone substance may affect the orbital floor, medial wall or lateral wall. These injuries can result in functional complications such as enophthalmos and diplopia, and an esthetic impact affecting the quality of life. The most frequent complication in orbital traumas is enophthalmos (10-20% according to publications).
The aim of bone substance reconstruction is to restore the volume and the internal shape of the orbit. The gold standard is autologous bone grafts. The surgery which usually lasts 2 to 3 hours depending on the number of walls involved, can lead to ophthalmological or esthetic complications. Its results are unsatisfactory, and the use of titanium implants would allow a reconstruction of the orbital volume more optimal than the autograft.
The development of computer-assisted techniques permitted implants evolution: initially peri-operatively preformed, today patient specific implant can be obtained from data of CT-scan. In cranioplasties, a randomized study showed better results at 12 months of these implants compared to the autograft. Their success rate is close to 100% with less than 5% of postoperative complication, while the rate used for cortical graft reconstructions is 20-25%.
Today, 3D printing of patient-specific porous titanium implants is possible. A study has shown that they allow a more accurate reconstruction compared to preformed implants. This innovation is available in France but it has a high cost (2,000 euros on average) and is currently not refunded. However, the use of this technology would reduce the operating time and the morbidity per- and post-operative, with functional and esthetic results superior to those obtained with bone autograft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autograft | Active comparator | Procedure: Bone autograftReconstructive surgery by autologous bone graft (bone autograft). It is the gold standard strategy. |
| 3D implant | Experimental | Procedure: Orbital reconstruction by 3D-printed porous titanium implantOrbital reconstruction by 3D-printed porous titanium implant (PorousiTi®, laboratoire OBL/MATERIALISE). The device is a custom-made porous titanium implant processed by selective laser melting (SLM technique) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient between 18 to 90 years old
- Presenting a defect in the bone substance of an orbital wall (floor, lateral or medial): at least 6 months following a oncologic surgery (in particular meningioma or carcinoma of the upper aerodigestive tract) OR post-traumatic;
- With a defect of the unilateral orbital bone substance described as complex on the CT-scan: fracture in the posterior third of one walls; fracture extended to two walls (floor and lateral wall, or medial wall and orbital floor); comminutive fracture of at least one of the walls; fracture with more than half of one of the walls tipped over;
- Presenting an enophthalmos ≥ 3 mm OR an enophthalmos ≥ 2mm with diplopia;
- Patient with a programmed orbital reconstruction;
Key exclusion criteria (9 listed)
- Defect of bone substance extended to the upper and / or intermediate floors of the skull-base;
- For patients who have undergone oncologic surgery, patients with uncontrolled cancer proliferation;
- Defect of bone substance from the skull vault;
- Osteo-meningeal Breach;
- Patient whose understand the French questionnaire EQ-5D-3L;
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 |
|---|---|---|
| Bone autograftThe principle of this surgery is based on the removal of a portion of the outer bone layer from the vault of the skull in order to have a flat and solid bone element (cortical bone), which can be carved freehand to better replace the defective bone wall. | Procedure or surgery | Autograft |
| Orbital reconstruction by 3D-printed porous titanium implantFrom data of a patient's CT-scan, it is possible to perform a "mirroring". The unaffected orbit is mirrored onto the affected orbit, via a virtual treatment planning, in order to rely on facial symmetry to virtually restore healthy anatomy. From this simulation, the implant is 3D-printed by Selective Laser Melted (SLM) technique using titanium powder. This technique enabling the creation of custom-made implants is called computer-aided design and computer-aided manufacturing (CAD-CAM). After sterilization, the implant is ready to be placed during a surgical procedure. | Procedure or surgery | 3D implant |
Primary outcome
Incremental cost per quality-adjusted life-years (QALY) gained
Time frame: 18 months
QALY will be measured by EQ-5D-3L questionnaire. At 18 months post reconstruction, we can estimate most of the costs of surgery and its consequences. Incremental cost per quality-adjusted life-years (QALY) gained between patients with 3D-printed patient specific porous titanium implant or autologous bone graft for orbital reconstruction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone autograft and Orbital reconstruction by 3D-printed porous titanium implant in people with Significant Bone Defect in the Orbit, run by Hospices Civils de Lyon at 1 site in France.
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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 6 May 2023. 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 France. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Thomas BACHELET (+33 4 26 73 26 44, jean-thomas.bachelet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental cost per quality-adjusted life-years (QALY) gained (time frame: 18 months). 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 6 May 2023.