Large Segmental Bone DefectNCT03941028
Clinical Effects of Large Segmental Bone Defects With 3D Printed Titanium Implant
A study testing 3D printed titanium implant in people with Large Segmental Bone Defect, run by Peking University Third Hospital at 1 site in China.
Trial summary
The investigators apply 3D printed titanium implant to treat bone defects. Without using bone grafts and growth factors, the investigators anticipate the titanium implant alone can help bone reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Segmental Bone Defect
- What is being tested?
- 3D printed titanium implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2019to 30 Dec 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bone defects caused by trauma or infection or tumor
- the length of bone defect is more than 6cm
- more than 18 years old
Who cannot join
- malignant tumor
- patients with bad conditions failing to tolerate surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yun Tian, MD, +8610-82267010, tiany@bjmu.edu.cn
About this study
Official title: Clinical Effects of Large Segmental Bone Defects Caused by Trauma, Infection and Tumor With 3D Printed Titanium Implant
The investigators apply 3D printed titanium implant to treat bone defects. Without using bone grafts and growth factors, the investigators anticipate the titanium implant alone can help bone reconstruction.
Read the detailed description
The investigators treat large segmental bone defects caused by three reasons, including trauma, infection and tumor. In this study, polyporous 3D printed titanium implant is applied to reconstruct the bone defects and the investigators will follow up patients' function and bone regeneration.
- Conditions
- Large Segmental Bone Defect
- Being tested
- 3D printed titanium implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed titanium implantDevice
The 3D printed titanium implant is fabricated by related companies. And some implants have been used in spinal disease in our hospital.
| Study group | Role | What they receive |
|---|---|---|
| bone defects caused by trauma | Experimental | Large bone defects (>6cm) caused by trauma Receives: Device: 3D printed titanium implant |
| bone defects caused by infection | Experimental | Large bone defects caused by chronic osteomyelitis Receives: Device: 3D printed titanium implant |
| bone defects caused by tumor | Experimental | Large bone defects caused by benign tumor Receives: Device: 3D printed titanium implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone reconstruction
X-rays and CT scans are used to evaluate the bone reconstruction
Measured: 1 year
Secondary outcomes (1)
Questionnaire of limb function
Restoration of limb function.
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 2019
- Study start12 Jan 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Segmental Bone DefectStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Tian, MD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941028
- Sponsor's protocol ID
- Z181100001718195
- Status last verified
- Apr 2019
- First submitted
- 15 Apr 2019
- Last updated
- 7 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Large Segmental Bone Defects Caused by Trauma, Infection and Tumor With 3D Printed Titanium Implant
- ClinicalTrials.gov ID
- NCT03941028
- Acronym / sponsor ID
- Z181100001718195
- Conditions
- Large Segmental Bone Defect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 12 Jan 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 7 May 2019 (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.
The investigators apply 3D printed titanium implant to treat bone defects. Without using bone grafts and growth factors, the investigators anticipate the titanium implant alone can help bone reconstruction.
Detailed description
The investigators treat large segmental bone defects caused by three reasons, including trauma, infection and tumor. In this study, polyporous 3D printed titanium implant is applied to reconstruct the bone defects and the investigators will follow up patients' function and bone regeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bone defects caused by trauma | Experimental | Device: 3D printed titanium implantLarge bone defects (>6cm) caused by trauma |
| bone defects caused by infection | Experimental | Device: 3D printed titanium implantLarge bone defects caused by chronic osteomyelitis |
| bone defects caused by tumor | Experimental | Device: 3D printed titanium implantLarge bone defects caused by benign tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- bone defects caused by trauma or infection or tumor
- the length of bone defect is more than 6cm
- more than 18 years old
Key exclusion criteria (2 listed)
- malignant tumor
- patients with bad conditions failing to tolerate surgery
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 |
|---|---|---|
| 3D printed titanium implantThe 3D printed titanium implant is fabricated by related companies. And some implants have been used in spinal disease in our hospital. | Device | bone defects caused by infection, bone defects caused by trauma, bone defects caused by tumor |
Primary outcome
Bone reconstruction
Time frame: 1 year
X-rays and CT scans are used to evaluate the bone reconstruction
1 secondary outcome
Questionnaire of limb function
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 7 May 2019.
- Individual participant dataSharing planned: No
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.
Yun Tian, MD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed titanium implant in people with Large Segmental Bone Defect, run by Peking University Third Hospital at 1 site in China.
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 3 inclusion and 2 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 7 May 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bingchuan Liu, MD (+86-18310188678, liubc@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone reconstruction (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 7 May 2019.