Bone DiseasesNCT03185286
3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects
A study testing 3d-printed personalized metal implant in people with Bone Diseases, run by Southwest Hospital, China at 1 site in China.
Trial summary
This study aims to use 3D-printed personalized metal implants for bone defect surgeries in order to reduce pain of the patients. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Bone Diseases
- What is being tested?
- 3d-printed personalized metal implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2015to 31 Dec 2019
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Receive ankle or subtalar arthrodesis;
- Refuse to use autologous bone graft or allogeneic bone graft.
Who cannot join
- The local defect area is small;
- Refuse to use permanent metal metal implant.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400030
Xiaojun Duan, MD, 86-23-68765290, duanxiaojun@hotmail.com
About this study
This study aims to use 3D-printed personalized metal implants for bone defect surgeries in order to reduce pain of the patients.
Read the detailed description
Bone defects are common in ankle disease, and the conventional treatment includes autologous or allogeneic bone grafts. However, autologous bone graft may cause complications and its source is rather limited; allogeneic bone graft may cause disease transmission and the mechanical strength of the graft is low after processing.
The 3D printing technology has provided a new way of solving this problem. It has the following technical advantages: wide range of graft sources, high mechanical strength, and can be prepared in advance according to various shapes.
Preparation procedure: first, establish the individualized ankle model according to the patient's ankle CT scan data and then prepare the implant model; second, conduct surgery rehearsal and place the implant model in the ankle model for observation; third, after confirmation, use titanium alloy in the 3D printing machine to prepare the individualized metal implant, which is in line with the Chinese National Standard "Wrought titanium and titanium alloy for surgical implants" (GB/T 13810-2007); fourth, implant the individualized metal implant into the bone defect area after sterilization.
- Conditions
- Bone Diseases
- Being tested
- 3d-printed personalized metal implant
- Keywords
- 3D printing, metal implant, bone defect
- Medical subject headings
- Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3d-printed personalized metal implantDevice
3d-printed personalized metal implant will be used in subtalar arthrodesis.
| Study group | Role | What they receive |
|---|---|---|
| 3D-printed personalized metal implant | Experimental | 3D-printed personalized metal implant will be used in bone defect surgeries. Receives: Device: 3d-printed personalized metal implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
The decrease in VAS score from baseline
Measured: Postoperative 24 months
Secondary outcomes (4)
American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale
The increase in AOFAS score from baseline
Measured: Postoperative 24 months
Lower limb alignment
Analyze the lower limb alignment by radiography
Measured: Postoperative 24 months
Osteotylus growth
Analyze the osteotylus growth by radiography
Measured: Postoperative 24 months
Implant displacement
Assess the implant displacement by radiography
Measured: Postoperative 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start31 Dec 2015
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DiseasesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Duan, Southwest Hospital, China
- Investigators
- Xiaojun Duan, MD, Principal investigator, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185286
- Sponsor's protocol ID
- 3DIMPLANT
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2017
- Last updated
- 14 Jun 2017
- 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 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects
- ClinicalTrials.gov ID
- NCT03185286
- Acronym / sponsor ID
- 3DIMPLANT
- Conditions
- Bone Diseases
- Keywords
- 3D printing, metal implant, bone defect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 31 Dec 2015 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 14 Jun 2017 (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.
This study aims to use 3D-printed personalized metal implants for bone defect surgeries in order to reduce pain of the patients.
Detailed description
Bone defects are common in ankle disease, and the conventional treatment includes autologous or allogeneic bone grafts. However, autologous bone graft may cause complications and its source is rather limited; allogeneic bone graft may cause disease transmission and the mechanical strength of the graft is low after processing.
The 3D printing technology has provided a new way of solving this problem. It has the following technical advantages: wide range of graft sources, high mechanical strength, and can be prepared in advance according to various shapes.
Preparation procedure: first, establish the individualized ankle model according to the patient's ankle CT scan data and then prepare the implant model; second, conduct surgery rehearsal and place the implant model in the ankle model for observation; third, after confirmation, use titanium alloy in the 3D printing machine to prepare the individualized metal implant, which is in line with the Chinese National Standard "Wrought titanium and titanium alloy for surgical implants" (GB/T 13810-2007); fourth, implant the individualized metal implant into the bone defect area after sterilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D-printed personalized metal implant | Experimental | Device: 3d-printed personalized metal implant3D-printed personalized metal implant will be used in bone defect surgeries. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Receive ankle or subtalar arthrodesis;
- Refuse to use autologous bone graft or allogeneic bone graft.
Key exclusion criteria (2 listed)
- The local defect area is small;
- Refuse to use permanent metal metal implant.
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 personalized metal implant3d-printed personalized metal implant will be used in subtalar arthrodesis. | Device | 3D-printed personalized metal implant |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: Postoperative 24 months
The decrease in VAS score from baseline
4 secondary outcomes
American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale
Time frame: Postoperative 24 months
Lower limb alignment
Time frame: Postoperative 24 months
Osteotylus growth
Time frame: Postoperative 24 months
Implant displacement
Time frame: Postoperative 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Xiaojun Duan, MD principal investigator
Southwest Hospital, China
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 personalized metal implant in people with Bone Diseases, run by Southwest Hospital, China 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 2 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 14 Jun 2017. 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 Xiaojun Duan, MD (86-23-68765290, duanxiaojun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: Postoperative 24 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 14 Jun 2017.