Large Bone DefectsNCT04466397
Repair of the Large Bone Defects Through 3D Printed Individualized Porous Implant
An observational study of Large Bone Defects, run by Peking University Third Hospital at 1 site in China.
Trial summary
The aim of this study was to investigate the simply use of three-dimensional (3D) printed individualized porous implants in the absence of autogenous/allogeneic bone graft or any osteoinductive agents to treat the large bone defects caused by varies of pathogenesis and systematically study its long-term therapeutic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Large Bone Defects
- What is being tested?
- 3D printed individualized porous implants
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 1 Jun 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients with bone tumor or bone infection who are diagnosed with large bone defects after receiving surgery in our Peking University Third Hospital.
Who may be able to join
- Large bone defects (>4cm) in spine, limb bone and hip joint caused by tumor, infection or other pathogenesis received the individualized porous implants treatment.Exclusion Criteria:
- Bone defects less than 4cm long.
- Bone defects treated by other methods ,such as ilizarov technique, masquelet technique or Ti mesh.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Teng Zhang, PhD, 8613385347899, zhangtengdoc@163.com
About this study
Official title: Repair of the Large Bone Defects Through 3D Printed Individualized Porous Implant: a New "Implant-bone" Interface Fusion Concept for Large Bone Defects Treatment
The aim of this study was to investigate the simply use of three-dimensional (3D) printed individualized porous implants in the absence of autogenous/allogeneic bone graft or any osteoinductive agents to treat the large bone defects caused by varies of pathogenesis and systematically study its long-term therapeutic effect and osseointegration characteristics.
Read the detailed description
A selection of fifty-eight patients with large bone defects caused by tumor, infection or trauma received the individualized porous implants treatment, and two typical cases were chosen for detailed study. Further, the large segmental femur defect model of sheep was utilized to study the osseointegration characteristics of the individualized porous implants in 1, 3, 6 months after implantation.
- Conditions
- Large Bone Defects
- Being tested
- 3D printed individualized porous implants
- Keywords
- large bone defects, 3D printed individualized porous implant, "implant-bone" interface fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed individualized porous implantsDevice
Use 3D printed individualized porous implants to reconstruct the large bone defects caused by tumor, infection or trauma.
| Study group | Role | What they receive |
|---|---|---|
| 3D printed implants reconstruction group | The patients with large bone defects who treated by 3D printed individualized porous implants Receives: Device: 3D printed individualized porous implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomechanical stability
Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
Measured: Immediate after the bone defect reconstruction.
Biomechanical stability
Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
Measured: 2 months after the bone defect reconstruction.
Biomechanical stability
Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
Measured: 5 months after the bone defect reconstruction.
Biomechanical stability
Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
Measured: 8 months after the bone defect reconstruction.
Biomechanical stability
Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
Measured: 14 months after the bone defect reconstruction.
Biomechanical stability
Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
Measured: 20 months after the bone defect reconstruction.
Secondary outcomes (6)
Osseointegration
Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.
Measured: Immediate after the bone defect reconstruction.
Osseointegration
Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.
Measured: 2 months after the bone defect reconstruction.
Osseointegration
Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.
Measured: 5 months after the bone defect reconstruction.
Osseointegration
Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.
Measured: 8 months after the bone defect reconstruction.
Osseointegration
Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.
Measured: 14 months after the bone defect reconstruction.
Osseointegration
Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.
Measured: 20 months after the bone defect reconstruction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start1 Jun 2018
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Bone DefectsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhongjun Liu, Bachelor, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466397
- Sponsor's protocol ID
- Liuzhongjun-1
- Status last verified
- Jun 2020
- First submitted
- 28 Jun 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- 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 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repair of the Large Bone Defects Through 3D Printed Individualized Porous Implant: a New "Implant-bone" Interface Fusion Concept for Large Bone Defects Treatment
- ClinicalTrials.gov ID
- NCT04466397
- Acronym / sponsor ID
- Liuzhongjun-1
- Conditions
- Large Bone Defects
- Keywords
- large bone defects, 3D printed individualized porous implant, "implant-bone" interface fusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 10 Jul 2020 (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 aim of this study was to investigate the simply use of three-dimensional (3D) printed individualized porous implants in the absence of autogenous/allogeneic bone graft or any osteoinductive agents to treat the large bone defects caused by varies of pathogenesis and systematically study its long-term therapeutic effect and osseointegration characteristics.
Detailed description
A selection of fifty-eight patients with large bone defects caused by tumor, infection or trauma received the individualized porous implants treatment, and two typical cases were chosen for detailed study. Further, the large segmental femur defect model of sheep was utilized to study the osseointegration characteristics of the individualized porous implants in 1, 3, 6 months after implantation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D printed implants reconstruction group | – | Device: 3D printed individualized porous implantsThe patients with large bone defects who treated by 3D printed individualized porous implants |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients with bone tumor or bone infection who are diagnosed with large bone defects after receiving surgery in our Peking University Third Hospital.
Key inclusion criteria (3 listed)
- Large bone defects (>4cm) in spine, limb bone and hip joint caused by tumor, infection or other pathogenesis received the individualized porous implants treatment.Exclusion Criteria:
- Bone defects less than 4cm long.
- Bone defects treated by other methods ,such as ilizarov technique, masquelet technique or Ti mesh.
Key exclusion criteria (0 listed)
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 individualized porous implantsUse 3D printed individualized porous implants to reconstruct the large bone defects caused by tumor, infection or trauma. | Device | 3D printed implants reconstruction group |
Primary outcome
Biomechanical stability
Time frame: Immediate after the bone defect reconstruction.
Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
Biomechanical stability
Time frame: 2 months after the bone defect reconstruction.
Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
Biomechanical stability
Time frame: 5 months after the bone defect reconstruction.
Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
Biomechanical stability
Time frame: 8 months after the bone defect reconstruction.
Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
Biomechanical stability
Time frame: 14 months after the bone defect reconstruction.
Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
Biomechanical stability
Time frame: 20 months after the bone defect reconstruction.
Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
6 secondary outcomes
Osseointegration
Time frame: Immediate after the bone defect reconstruction.
Osseointegration
Time frame: 2 months after the bone defect reconstruction.
Osseointegration
Time frame: 5 months after the bone defect reconstruction.
Osseointegration
Time frame: 8 months after the bone defect reconstruction.
Osseointegration
Time frame: 14 months after the bone defect reconstruction.
Osseointegration
Time frame: 20 months after the bone defect reconstruction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- 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.
Zhongjun Liu, Bachelor 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?
An observational study of Large Bone Defects, 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 0 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 10 Jul 2020. 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 Teng Zhang, PhD (8613385347899, zhangtengdoc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomechanical stability (time frame: Immediate after the bone defect reconstruction.). The study lists 6 primary outcomes in all. 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 10 Jul 2020.