Degradation of Magnesium Alloy Prosthesis and New Bone RegenerationNCT06349629
The Clinical Study of 3D-printed Magnesium Alloy Prosthesis With Controllable Degradation Rate in the Repair of Periarticular Bone Defects
A study testing 3D printed WE43 magnesium alloy in people with Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration, run by Peking University Third Hospital at 2 sites in China.
Trial summary
Perimarticular fracture bone defect is a common and complicated clinical disease. The current treatment for this type of injury is anatomical reduction of the fracture, where the bone defect is filled with artificial, autologous or allogeneic bone in granular form, and then fixed with plates and screws. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration
- What is being tested?
- 3D printed WE43 magnesium alloy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2023to 1 Jan 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with traumatic periarticular fractures of extremities with bone defects requiring bone grafting mainly include distal radius fractures, proximal humerus fractures, and tibial plateau fractures.
- Between the ages of 18 and 70.
- Sign informed consent, voluntarily participate in the study, and complete postoperative follow-up.
- There are no obvious surgical contraindications and no contraindications for magnesium alloy prosthesis implantation.
Who cannot join
- Patients with pathological fracture ② pregnant women ③ doctors evaluated other conditions that were not suitable for inclusion
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Haidian
Bingchuan Liu, +86 18310188678, liubc@bjmu.edu.cn
- Recruiting
Peking University Third Hospita
Beijing, 100083
Yun Tian, M.D, +8613701053505, tiany@bjmu.edu.cn
About this study
Perimarticular fracture bone defect is a common and complicated clinical disease. The current treatment for this type of injury is anatomical reduction of the fracture, where the bone defect is filled with artificial, autologous or allogeneic bone in granular form, and then fixed with plates and screws. However, these bone filler materials exist in a loose accumulation state and cannot form an effective overall support force for the joint. The applicant realized three dimensional (3D) printing of WE43 magnesium alloy with personalized design and porous overall structure, and developed high-temperature heat treatment technology to slow its degradation, which effectively realized the dual stability of degradation rate of magnesium alloy support body and overall structure during the bone repair period. This project will optimize the design of 3D printed WE43 magnesium alloy full-structure in-bone support, and establish a metamaterial pore structure design platform that regulates the physical properties and degradation behavior of porous implants. Fracture from proximal humerus, distal radius and tibial plateau
- Being tested
- 3D printed WE43 magnesium alloy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed WE43 magnesium alloyDevice
This 3D printed WE43 magnesium alloy has porous structure and suitable mechanical strength, can be stable in the bone support, and gradually degrade to promote bone healing.
| Study group | Role | What they receive |
|---|---|---|
| Clinical effect of 3D printed magnesium alloy prosthesis for repairing proximal humerus bone defect. | Experimental | The 3D printed magnesium alloy prosthesis is used to repair the proximal humerus fracture with bone defect, and the dynamic process of prosthesis degradation, fracture healing and new bone growth will be observed. Receives: Device: 3D printed WE43 magnesium alloy |
| Clinical effect of 3D printed magnesium alloy prosthesis for repairing distal radius bone defect. | Experimental | The 3D printed magnesium alloy prosthesis is used to repair the distal radius fracture with bone defect, and the dynamic process of prosthesis degradation, fracture healing and new bone growth will be observed. Receives: Device: 3D printed WE43 magnesium alloy |
| Clinical effect of 3D printed magnesium alloy prosthesis for repairing tibial plateau bone defect. | Experimental | The 3D printed magnesium alloy prosthesis is used to repair the tibial plateau fracture with bone defect, and the dynamic process of prosthesis degradation, fracture healing and new bone growth will be observed. Receives: Device: 3D printed WE43 magnesium alloy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Magnesium alloy metabolism
Blood routine, electrolyte, liver and kidney function, urine routine were used to evaluate magnesium alloy metabolism in vivo.
Measured: 1, 3, 6, 12, 24 months after surgery
Degradation of 3D printed magnesium alloy prosthesis
X-ray and computed tomography (CT) scans were used to evaluate the degradation progression of 3D printed magnesium alloy prosthesis
Measured: 1, 3, 6, 12, 24 months after surgery
New bone regeneration
X-ray and CT scans were used to evaluate the process of new bone regeneration
Measured: 1, 3, 6, 12, 24 months after surgery
Evaluation of shoulder joint function
American Shoulder and Elbow Surgeon's Form (ASES) was used to evaluate the shoulder joint function. The score scale of this form was 0 to 100, higher score represents better shoulder joint function.
Measured: 1, 3, 6, 12, 24 months after surgery
Evaluation of wrist joint function
Mayo Wrist Score was used to evaluate the wrist joint function.The score scale of this form was 0 to 100, higher score represents better joint function.
Measured: 1, 3, 6, 12, 24 months after surgery
Evaluation of knee joint function
Knee Society Score (KSS) was used to evaluate the knee joint function.The score scale of this form was 0 to 100, higher score represents better joint function.
Measured: 1, 3, 6, 12, 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Jan 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degradation of Magnesium Alloy Prosthesis and New Bone RegenerationStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tian Yun, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349629
- Sponsor's protocol ID
- 20240401
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of 3D-printed Magnesium Alloy Prosthesis With Controllable Degradation Rate in the Repair of Periarticular Bone Defects
- ClinicalTrials.gov ID
- NCT06349629
- Acronym / sponsor ID
- 20240401
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 5 Apr 2024 (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.
Perimarticular fracture bone defect is a common and complicated clinical disease. The current treatment for this type of injury is anatomical reduction of the fracture, where the bone defect is filled with artificial, autologous or allogeneic bone in granular form, and then fixed with plates and screws. However, these bone filler materials exist in a loose accumulation state and cannot form an effective overall support force for the joint. The applicant realized three dimensional (3D) printing of WE43 magnesium alloy with personalized design and porous overall structure, and developed high-temperature heat treatment technology to slow its degradation, which effectively realized the dual stability of degradation rate of magnesium alloy support body and overall structure during the bone repair period. This project will optimize the design of 3D printed WE43 magnesium alloy full-structure in-bone support, and establish a metamaterial pore structure design platform that regulates the physical properties and degradation behavior of porous implants. Fracture from proximal humerus, distal radius and tibial plateau
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinical effect of 3D printed magnesium alloy prosthesis for repairing proximal humerus bone defect. | Experimental | Device: 3D printed WE43 magnesium alloyThe 3D printed magnesium alloy prosthesis is used to repair the proximal humerus fracture with bone defect, and the dynamic process of prosthesis degradation, fracture healing and new bone growth will be observed. |
| Clinical effect of 3D printed magnesium alloy prosthesis for repairing distal radius bone defect. | Experimental | Device: 3D printed WE43 magnesium alloyThe 3D printed magnesium alloy prosthesis is used to repair the distal radius fracture with bone defect, and the dynamic process of prosthesis degradation, fracture healing and new bone growth will be observed. |
| Clinical effect of 3D printed magnesium alloy prosthesis for repairing tibial plateau bone defect. | Experimental | Device: 3D printed WE43 magnesium alloyThe 3D printed magnesium alloy prosthesis is used to repair the tibial plateau fracture with bone defect, and the dynamic process of prosthesis degradation, fracture healing and new bone growth will be observed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with traumatic periarticular fractures of extremities with bone defects requiring bone grafting mainly include distal radius fractures, proximal humerus fractures, and tibial plateau fractures.
- Between the ages of 18 and 70.
- Sign informed consent, voluntarily participate in the study, and complete postoperative follow-up.
- There are no obvious surgical contraindications and no contraindications for magnesium alloy prosthesis implantation.
Key exclusion criteria (1 listed)
- Patients with pathological fracture ② pregnant women ③ doctors evaluated other conditions that were not suitable for inclusion
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 WE43 magnesium alloyThis 3D printed WE43 magnesium alloy has porous structure and suitable mechanical strength, can be stable in the bone support, and gradually degrade to promote bone healing. | Device | Clinical effect of 3D printed magnesium alloy prosthesis for repairing distal radius bone defect., Clinical effect of 3D printed magnesium alloy prosthesis for repairing proximal humerus bone defect., Clinical effect of 3D printed magnesium alloy prosthesis for repairing tibial plateau bone defect. |
Primary outcome
Detection of Magnesium alloy metabolism
Time frame: 1, 3, 6, 12, 24 months after surgery
Blood routine, electrolyte, liver and kidney function, urine routine were used to evaluate magnesium alloy metabolism in vivo.
Degradation of 3D printed magnesium alloy prosthesis
Time frame: 1, 3, 6, 12, 24 months after surgery
X-ray and computed tomography (CT) scans were used to evaluate the degradation progression of 3D printed magnesium alloy prosthesis
New bone regeneration
Time frame: 1, 3, 6, 12, 24 months after surgery
X-ray and CT scans were used to evaluate the process of new bone regeneration
Evaluation of shoulder joint function
Time frame: 1, 3, 6, 12, 24 months after surgery
American Shoulder and Elbow Surgeon's Form (ASES) was used to evaluate the shoulder joint function. The score scale of this form was 0 to 100, higher score represents better shoulder joint function.
Evaluation of wrist joint function
Time frame: 1, 3, 6, 12, 24 months after surgery
Mayo Wrist Score was used to evaluate the wrist joint function.The score scale of this form was 0 to 100, higher score represents better joint function.
Evaluation of knee joint function
Time frame: 1, 3, 6, 12, 24 months after surgery
Knee Society Score (KSS) was used to evaluate the knee joint function.The score scale of this form was 0 to 100, higher score represents better joint function.
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 5 Apr 2024.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed WE43 magnesium alloy in people with Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration, run by Peking University Third Hospital at 2 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 4 inclusion and 1 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 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 Yun Tian, MD (010-82267010, tiany@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Magnesium alloy metabolism (time frame: 1, 3, 6, 12, 24 months after surgery). 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 5 Apr 2024.