Defect; Internal Prosthetic Device, Implants and Grafts, Orthopedic, Bone GraftNCT03166917
Clinical Application of Personal Designed 3D Printing Implants in Bone Defect Restoration
A study testing 3D printing implant and autogenous bone grafting in people with Defect; Internal Prosthetic Device, Implants and Grafts, Orthopedic, Bone Graft, run by fang guofang at 3 sites in China.
Trial summary
Objective: Clinical application of 3D printing implant in bone defect treatment. Study design: multicenter randomized controlled study . Methods:patients randomly grouped according to register number into internal fixation and bone graft group and 3D printing group. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Defect; Internal Prosthetic Device, Implants and Grafts, Orthopedic, Bone Graft
- What is being tested?
- 3D printing implant and autogenous bone grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jul 2017to 31 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Open fracture with bone defect
- Burst fracture of spine with bone defect
- Bone tumor with bone defect
- Bone tuberculosis with bone defect
- Nonunion with bone defect
Who cannot join
- Patients who can not tolerate anesthesia and surgery due to severe impairment of heart and lung function
- Systemic or local infection
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou
gang wang, doctor, 13902989637, 13902989637@139.com
- Recruiting
Zhujing hospital of southern medical university
Guanzhou
lixin Zhu, doctor, 13926114760, 13926114760@139.com
- Recruiting
Shenzhen Hospital of Southern Medical University
Shenzhen
guofang fang, doctor, 18820153828, fanguofan@163.com
About this study
Official title: Shenzhen Hospital of Southern Medical University
Objective: Clinical application of 3D printing implant in bone defect treatment.
Study design: multicenter randomized controlled study . Methods:patients randomly grouped according to register number into internal fixation and bone graft group and 3D printing group. Reconstruct 3D models ,evaluate models preoperatively , simulate surgery in computer,design 3D implant, and 3D print implants,perform surgery with 3D implants to achieve the greatest degree of physiological reconstruction.Evaluate surgical efficacy .
- Being tested
- 3D printing implant, autogenous bone grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printing implantProcedure or surgery
3D printing implants in bone defect
autogenous bone graftingProcedure or surgery
3D printing implants in bone defect
| Study group | Role | What they receive |
|---|---|---|
| 3D printing implant | Experimental | 3D printing implant in bone defect Receives: Procedure: 3D printing implant |
| Autogenous bone grafting | Placebo comparator | autogenous bone grafting in bone defect Receives: Procedure: autogenous bone grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Defect; Internal Prosthetic Device, Implants and Grafts, Orthopedic, Bone GraftStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- fang guofang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, fang guofang, Shenzhen Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166917
- Sponsor's protocol ID
- C1033429
- Status last verified
- May 2017
- First submitted
- 24 May 2017
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Li X, Wang Y, Zhao Y, Liu J, Xiao S, Mao K. Multilevel 3D Printing Implant for Reconstructing Cervical Spine With Metastatic Papillary Thyroid Carcinoma. Spine (Phila Pa 1976). 2017 Nov 15;42(22):E1326-E1330. doi: 10.1097/BRS.0000000000002229.
PubMed 28498291Yang F, Chen C, Zhou Q, Gong Y, Li R, Li C, Klampfl F, Freund S, Wu X, Sun Y, Li X, Schmidt M, Ma D, Yu Y. Laser beam melting 3D printing of Ti6Al4V based porous structured dental implants: fabrication, biocompatibility analysis and photoelastic study. Sci Rep. 2017 Mar 28;7:45360. doi: 10.1038/srep45360.
PubMed 28350007Mustafa SF, Evans PL, Sugar AW, Key SJ. Streamlining the manufacture of custom titanium orbital plates with a stereolithographic three-dimensional printed model. Br J Oral Maxillofac Surg. 2017 Jun;55(5):546-547. doi: 10.1016/j.bjoms.2016.03.003. Epub 2017 Apr 6. No abstract available.
PubMed 28392025Tan XP, Tan YJ, Chow CSL, Tor SB, Yeong WY. Metallic powder-bed based 3D printing of cellular scaffolds for orthopaedic implants: A state-of-the-art review on manufacturing, topological design, mechanical properties and biocompatibility. Mater Sci Eng C Mater Biol Appl. 2017 Jul 1;76:1328-1343. doi: 10.1016/j.msec.2017.02.094. Epub 2017 Feb 24.
PubMed 28482501
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shenzhen Hospital of Southern Medical University
- ClinicalTrials.gov ID
- NCT03166917
- Acronym / sponsor ID
- C1033429
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- fang guofangUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 25 May 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.
Objective: Clinical application of 3D printing implant in bone defect treatment.
Study design: multicenter randomized controlled study . Methods:patients randomly grouped according to register number into internal fixation and bone graft group and 3D printing group. Reconstruct 3D models ,evaluate models preoperatively , simulate surgery in computer,design 3D implant, and 3D print implants,perform surgery with 3D implants to achieve the greatest degree of physiological reconstruction.Evaluate surgical efficacy .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D printing implant | Experimental | Procedure: 3D printing implant3D printing implant in bone defect |
| Autogenous bone grafting | Placebo comparator | Procedure: autogenous bone graftingautogenous bone grafting in bone defect |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Open fracture with bone defect
- Burst fracture of spine with bone defect
- Bone tumor with bone defect
- Bone tuberculosis with bone defect
- Nonunion with bone defect
Key exclusion criteria (2 listed)
- Patients who can not tolerate anesthesia and surgery due to severe impairment of heart and lung function
- Systemic or local infection
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 printing implant3D printing implants in bone defect | Procedure or surgery | 3D printing implant |
| autogenous bone grafting3D printing implants in bone defect | Procedure or surgery | Autogenous bone grafting |
Primary outcome
operative time
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Background: PubMed 28498291Li X, Wang Y, Zhao Y, Liu J, Xiao S, Mao K. Multilevel 3D Printing Implant for Reconstructing Cervical Spine With Metastatic Papillary Thyroid Carcinoma. Spine (Phila Pa 1976). 2017 Nov 15;42(22):E1326-E1330. doi: 10.1097/BRS.0000000000002229.
- Background: PubMed 28350007Yang F, Chen C, Zhou Q, Gong Y, Li R, Li C, Klampfl F, Freund S, Wu X, Sun Y, Li X, Schmidt M, Ma D, Yu Y. Laser beam melting 3D printing of Ti6Al4V based porous structured dental implants: fabrication, biocompatibility analysis and photoelastic study. Sci Rep. 2017 Mar 28;7:45360. doi: 10.1038/srep45360.
- Background: PubMed 28392025Mustafa SF, Evans PL, Sugar AW, Key SJ. Streamlining the manufacture of custom titanium orbital plates with a stereolithographic three-dimensional printed model. Br J Oral Maxillofac Surg. 2017 Jun;55(5):546-547. doi: 10.1016/j.bjoms.2016.03.003. Epub 2017 Apr 6. No abstract available.
- Background: PubMed 28482501Tan XP, Tan YJ, Chow CSL, Tor SB, Yeong WY. Metallic powder-bed based 3D printing of cellular scaffolds for orthopaedic implants: A state-of-the-art review on manufacturing, topological design, mechanical properties and biocompatibility. Mater Sci Eng C Mater Biol Appl. 2017 Jul 1;76:1328-1343. doi: 10.1016/j.msec.2017.02.094. Epub 2017 Feb 24.
- Individual participant dataSharing planned: Yes
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printing implant and autogenous bone grafting in people with Defect; Internal Prosthetic Device, Implants and Grafts, Orthopedic, Bone Graft, run by fang guofang at 3 sites 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 5 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 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
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?
operative time (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03166917, which also lists 4 linked publications.
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 25 May 2017.