Periarticular Bone DefectMgScaf-PBDNCT07906730
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
A study testing Magnesium Alloy Scaffold and Calcium Sulfate Bone Graft Substitute in people with Periarticular Bone Defect and Proximal Humerus Fracture, run by Peking University Third Hospital at 4 sites in China.
Trial summary
This prospective, multi-center, randomized controlled clinical trial is designed to evaluate the effectiveness and safety of a biodegradable magnesium alloy scaffold with controlled degradation for the treatment of periarticular bone defects of the extremities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periarticular Bone Defect, Proximal Humerus Fracture, Distal Radius Fracture
- What is being tested?
- Magnesium Alloy Scaffold and Calcium Sulfate Bone Graft Substitute
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesChina
- Study dates
- 1 Nov 2026to 30 Jun 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older, regardless of sex.
- Radiographically confirmed proximal humerus fracture, tibial plateau fracture, or distal radius fracture associated with a bone defect and requiring surgical treatment.
- Willing to participate in the clinical trial and able to provide written informed consent.
Who cannot join
- Active systemic infection or active infection at the planned surgical site that may interfere with surgery.
- Pathological fracture, compartment syndrome, osteomyelitis, or severe soft-tissue, vascular, or nerve injury.
- History of allergy or hypersensitivity to magnesium alloy or titanium alloy implant materials.
- Psychiatric illness, inability to comply with study procedures for any reason, or unwillingness or inability to comply with required activity restrictions.
- Drug abuse or alcohol abuse, or inability to refrain from smoking during fracture healing.
- Women who are pregnant or breastfeeding, or women planning to become pregnant during the study period.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for this clinical trial.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Beijing Chao Yang Hospital
Beijing, Beijing Municipality
Beijing Friendship Hospital
Beijing, Beijing Municipality
Beijing Hospital
Beijing, Beijing Municipality
Peking University Third Hospital
Beijing, Beijing Municipality
About this study
Official title: Clinical Study of a Magnesium Alloy Scaffold With Controlled Degradation for the Treatment of Periarticular Bone Defects of the Extremities
This prospective, multi-center, randomized controlled clinical trial is designed to evaluate the effectiveness and safety of a biodegradable magnesium alloy scaffold with controlled degradation for the treatment of periarticular bone defects of the extremities. Adults with proximal humeral fractures, distal radius fractures, or tibial plateau fractures associated with bone defects and requiring surgical treatment will be enrolled. A total of 120 participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group.
Participants in the experimental group will undergo open reduction and internal fixation with implantation of a customized magnesium alloy scaffold into the bone defect. Participants in the control group will undergo conventional open reduction and internal fixation with calcium sulfate bone graft substitute used to fill the bone defect.
Participants will be followed for up to 48 weeks after surgery. The study will primarily evaluate bone healing, and will also assess joint function, wound healing, degradation of the magnesium alloy scaffold, device performance, laboratory parameters, and adverse events.
Read the detailed description
Periarticular fractures involving bone defects can compromise structural support beneath the articular surface and may increase the risk of loss of reduction, secondary articular collapse, impaired joint function, and delayed bone healing. Conventional bone defect fillers, including particulate bone graft substitutes, provide defect filling but may have limited structural stability. A biodegradable magnesium alloy scaffold with controlled degradation is intended to provide temporary structural support within the bone defect while allowing gradual degradation during the process of bone healing.
This is a prospective, multi-center, participant-blinded, randomized controlled trial. A total of 120 adult participants with proximal humeral fractures, distal radius fractures, or tibial plateau fractures associated with bone defects will be enrolled and randomly assigned in a 1:1 ratio. In the experimental group, a customized magnesium alloy scaffold will be implanted into the bone defect following fracture reduction, together with conventional plate-and-screw fixation. In the control group, the fracture will be treated with conventional open reduction and internal fixation, and the bone defect will be filled with calcium sulfate granules. Because the two interventions are visually distinguishable during surgery, treating investigators cannot be blinded; however, participants will be blinded to treatment allocation, and independent assessors will perform blinded evaluation of clinical and imaging data.
Participants will undergo clinical, imaging, functional, laboratory, and safety assessments during follow-up through 48 weeks after surgery. Routine safety monitoring will include vital signs, laboratory assessments, and surveillance for adverse events (AEs) and serious adverse events (SAEs).
Vital signs, including body temperature, pulse rate, blood pressure, and respiratory rate, will be assessed preoperatively, on the day of surgery, within 3 days after surgery, and at 4, 8, 12, 24, and 48 weeks after surgery.
Routine laboratory safety assessments will be performed preoperatively and at 4, 12, 24, and 48 weeks after surgery. These assessments will include complete blood count (red blood cell count, hemoglobin concentration, white blood cell count, platelet count, and neutrophil percentage), liver function tests (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]), renal function tests (serum creatinine and blood urea nitrogen), serum magnesium, serum potassium, and C-reactive protein (CRP).
Actual laboratory values and clinically relevant abnormalities will be documented in the case report forms and reviewed by the investigators as part of routine safety monitoring. Any clinically significant abnormalities will be evaluated and managed according to the study protocol and applicable clinical standards.
Adverse events and serious adverse events will be monitored throughout the study. Relevant information, including event type, onset, severity, management, relationship to the investigational device or study procedure, duration, and outcome, will be documented.
The study is designed to determine whether the magnesium alloy scaffold can provide effective structural support and promote bone healing while maintaining an acceptable safety profile.
- Conditions
- Periarticular Bone Defect, Proximal Humerus Fracture, Distal Radius Fracture, Tibial Plateau Fracture
- Being tested
- Magnesium Alloy Scaffold, Calcium Sulfate Bone Graft Substitute
- Keywords
- Periarticular Bone Defect, Magnesium Alloy Scaffold, Biodegradable Magnesium Alloy, Controlled Degradation, Bone Healing, Internal Fixation, Calcium Sulfate Bone Graft Substitute
- Medical subject headings
- Wrist Fractures, Tibial Plateau Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Alloy ScaffoldDevice
A customized biodegradable magnesium alloy scaffold with controlled degradation will be implanted into the periarticular bone defect during open reduction and internal fixation to provide structural support and facilitate bone healing.
Calcium Sulfate Bone Graft SubstituteDevice
Calcium sulfate granules will be used to fill the periarticular bone defect during conventional open reduction and internal fixation.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Alloy Scaffold Group | Experimental | Participants will undergo open reduction and internal fixation. A customized biodegradable magnesium alloy scaffold with controlled degradation will be implanted into the periarticular bone defect to provide structural support, followed by plate-and-screw fixation. Receives: Device: Magnesium Alloy Scaffold |
| Calcium Sulfate Group | Active comparator | Participants will undergo conventional open reduction and internal fixation. The periarticular bone defect will be filled with calcium sulfate bone graft substitute. Receives: Device: Calcium Sulfate Bone Graft Substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Union Rate
Bone union will be considered achieved when both of the following criteria are met: (1) no local tenderness or axial percussion pain and no abnormal mobility at the fracture site; and (2) imaging demonstrates continuous callus or trabecular bone crossing the fracture line, with the fracture line becoming indistinct. The outcome will be reported as the percentage of participants meeting both criteria.
Measured: 48 weeks after surgery
Secondary outcomes (9)
Barthel Index Score for Activities of Daily Living
The Barthel Index assesses functional independence in basic activities of daily living, including feeding, bathing, grooming, dressing, toileting, transfers, mobility, and stair climbing. The total score ranges from 0 to 100, with higher scores indicating greater independence and better functional outcomes.
Measured: 4, 8, 12, 24, and 48 weeks after surgery
Patient-Rated Wrist Evaluation (PRWE) Score
The Patient-Rated Wrist Evaluation (PRWE) is a 15-item patient-reported questionnaire assessing wrist pain and functional disability. It consists of a pain subscale (0-50 points) and a function subscale (0-50 points). The total score ranges from 0 to 100, with lower scores indicating less pain, less disability, and better wrist function. This outcome will be assessed in participants with distal radius fractures.
Measured: 4, 8, 12, 24, and 48 weeks after surgery
Hospital for Special Surgery (HSS) Knee Score
The Hospital for Special Surgery (HSS) Knee Score assesses knee function based on pain, functional capacity, range of motion, muscle strength, and other clinical findings. The total score ranges from 0 to 100, with higher scores indicating better knee function. This outcome will be assessed in participants with tibial plateau fractures.
Measured: 4, 8, 12, 24, and 48 weeks after surgery
American Shoulder and Elbow Surgeons (ASES) Score
The American Shoulder and Elbow Surgeons (ASES) Shoulder Score assesses shoulder pain and functional ability in activities of daily living. The standardized total score ranges from 0 to 100, with higher scores indicating less pain and better shoulder function. This outcome will be assessed in participants with proximal humeral fractures.
Measured: 4, 8, 12, 24, and 48 weeks after surgery
Constant-Murley Shoulder Score
The Constant-Murley Shoulder Score assesses shoulder function based on pain, activities of daily living, range of motion, and muscle strength. The total score ranges from 0 to 100, with higher scores indicating better shoulder function. This outcome will be assessed in participants with proximal humeral fractures.
Measured: 4, 8, 12, 24, and 48 weeks after surgery
Incision Healing Grade
Incision healing will be classified as Grade A (good healing), Grade B (suboptimal healing), or Grade C (purulent wound healing).
Measured: 4 and 8 weeks after surgery
Number of Participants Meeting All Four Device Performance Criteria
Device performance will be evaluated using four predefined Yes/No criteria: (1) integrity of sterile packaging; (2) clarity, completeness, and legibility of device labeling and instructions for use; (3) compatibility of the associated surgical instruments; and (4) ease of device implantation. A participant will be classified as meeting the overall device performance criteria only if all four items are rated "Yes". The number and percentage of participants meeting all four criteria will be reported in the experimental group.
Measured: Day of surgery
Distribution of Participants by CT-Assessed Magnesium Alloy Scaffold Degradation Grade at Week 24
Scaffold morphological degradation will be assessed in the experimental group by computed tomography (CT) at Week 24, compared with CT obtained within 3 days after surgery. Plain radiographs will provide supportive information. A study-specific 5-grade ordinal classification will be used: Grade 0, no detectable morphological change; Grade 1, localized contour irregularity or thinning with preserved strut continuity; Grade 2, focal strut discontinuity or partial structural loss with the overall architecture recognizable; Grade 3, extensive strut discontinuity or fragmentation with residual scaffold structures identifiable; Grade 4, no identifiable residual metallic scaffold structure. Higher grades indicate greater CT-visible morphological degradation, not a measured percentage of alloy mass loss. The number and percentage of participants in each grade will be reported.
Measured: 24 weeks after surgery
Distribution of Participants by CT-Assessed Magnesium Alloy Scaffold Degradation Grade at Week 48
Scaffold morphological degradation will be assessed in the experimental group by computed tomography (CT) at Week 48, compared with CT obtained within 3 days after surgery. Plain radiographs will provide supportive information. A study-specific 5-grade ordinal classification will be used: Grade 0, no detectable morphological change; Grade 1, localized contour irregularity or thinning with preserved strut continuity; Grade 2, focal strut discontinuity or partial structural loss with the overall architecture recognizable; Grade 3, extensive strut discontinuity or fragmentation with residual scaffold structures identifiable; Grade 4, no identifiable residual metallic scaffold structure. Higher grades indicate greater CT-visible morphological degradation, not a measured percentage of alloy mass loss. The number and percentage of participants in each grade will be reported.
Measured: 48 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periarticular 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to the experimental group receiving a magnesium alloy scaffold or the control group receiving calcium sulfate bone graft substitute. The two groups will be followed in parallel through 48 weeks after surgery.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Hospital, Beijing AK Medical Co., Ltd., Beijing Friendship Hospital
- Responsible party
- Sponsor
- Investigators
- Yun Tian, MD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906730
- Sponsor's protocol ID
- PUTH-3DMg-PBD-01
- Other IDs
- 2024-1-4092
- Acronym
- MgScaf-PBD
- Status last verified
- Sep 2026
- First submitted
- 9 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu B, Liu J, Wang C, Wang Z, Min S, Wang C, Zheng Y, Wen P, Tian Y. High temperature oxidation treated 3D printed anatomical WE43 alloy scaffolds for repairing periarticular bone defects: In vitro and in vivo studies. Bioact Mater. 2023 Oct 11;32:177-189. doi: 10.1016/j.bioactmat.2023.09.016. eCollection 2024 Feb.
PubMed 37859690
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of a Magnesium Alloy Scaffold With Controlled Degradation for the Treatment of Periarticular Bone Defects of the Extremities
- ClinicalTrials.gov ID
- NCT07906730
- Acronym / sponsor ID
- MgScaf-PBD / PUTH-3DMg-PBD-01
- Conditions
- Periarticular Bone Defect, Proximal Humerus Fracture, Distal Radius Fracture, Tibial Plateau Fracture
- Keywords
- Periarticular Bone Defect, Magnesium Alloy Scaffold, Biodegradable Magnesium Alloy, Controlled Degradation, Bone Healing, Internal Fixation, Calcium Sulfate Bone Graft Substitute
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Hospital, Beijing AK Medical Co., Ltd., Beijing Friendship Hospital
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 30 Oct 2026 (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 prospective, multi-center, randomized controlled clinical trial is designed to evaluate the effectiveness and safety of a biodegradable magnesium alloy scaffold with controlled degradation for the treatment of periarticular bone defects of the extremities. Adults with proximal humeral fractures, distal radius fractures, or tibial plateau fractures associated with bone defects and requiring surgical treatment will be enrolled. A total of 120 participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group.
Participants in the experimental group will undergo open reduction and internal fixation with implantation of a customized magnesium alloy scaffold into the bone defect. Participants in the control group will undergo conventional open reduction and internal fixation with calcium sulfate bone graft substitute used to fill the bone defect.
Participants will be followed for up to 48 weeks after surgery. The study will primarily evaluate bone healing, and will also assess joint function, wound healing, degradation of the magnesium alloy scaffold, device performance, laboratory parameters, and adverse events.
Detailed description
Periarticular fractures involving bone defects can compromise structural support beneath the articular surface and may increase the risk of loss of reduction, secondary articular collapse, impaired joint function, and delayed bone healing. Conventional bone defect fillers, including particulate bone graft substitutes, provide defect filling but may have limited structural stability. A biodegradable magnesium alloy scaffold with controlled degradation is intended to provide temporary structural support within the bone defect while allowing gradual degradation during the process of bone healing.
This is a prospective, multi-center, participant-blinded, randomized controlled trial. A total of 120 adult participants with proximal humeral fractures, distal radius fractures, or tibial plateau fractures associated with bone defects will be enrolled and randomly assigned in a 1:1 ratio. In the experimental group, a customized magnesium alloy scaffold will be implanted into the bone defect following fracture reduction, together with conventional plate-and-screw fixation. In the control group, the fracture will be treated with conventional open reduction and internal fixation, and the bone defect will be filled with calcium sulfate granules. Because the two interventions are visually distinguishable during surgery, treating investigators cannot be blinded; however, participants will be blinded to treatment allocation, and independent assessors will perform blinded evaluation of clinical and imaging data.
Participants will undergo clinical, imaging, functional, laboratory, and safety assessments during follow-up through 48 weeks after surgery. Routine safety monitoring will include vital signs, laboratory assessments, and surveillance for adverse events (AEs) and serious adverse events (SAEs).
Vital signs, including body temperature, pulse rate, blood pressure, and respiratory rate, will be assessed preoperatively, on the day of surgery, within 3 days after surgery, and at 4, 8, 12, 24, and 48 weeks after surgery.
Routine laboratory safety assessments will be performed preoperatively and at 4, 12, 24, and 48 weeks after surgery. These assessments will include complete blood count (red blood cell count, hemoglobin concentration, white blood cell count, platelet count, and neutrophil percentage), liver function tests (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]), renal function tests (serum creatinine and blood urea nitrogen), serum magnesium, serum potassium, and C-reactive protein (CRP).
Actual laboratory values and clinically relevant abnormalities will be documented in the case report forms and reviewed by the investigators as part of routine safety monitoring. Any clinically significant abnormalities will be evaluated and managed according to the study protocol and applicable clinical standards.
Adverse events and serious adverse events will be monitored throughout the study. Relevant information, including event type, onset, severity, management, relationship to the investigational device or study procedure, duration, and outcome, will be documented.
The study is designed to determine whether the magnesium alloy scaffold can provide effective structural support and promote bone healing while maintaining an acceptable safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to the experimental group receiving a magnesium alloy scaffold or the control group receiving calcium sulfate bone graft substitute. The two groups will be followed in parallel through 48 weeks after surgery.
| Arm | Type | Receives |
|---|---|---|
| Magnesium Alloy Scaffold Group | Experimental | Device: Magnesium Alloy ScaffoldParticipants will undergo open reduction and internal fixation. A customized biodegradable magnesium alloy scaffold with controlled degradation will be implanted into the periarticular bone defect to provide structural support, followed by plate-and-screw fixation. |
| Calcium Sulfate Group | Active comparator | Device: Calcium Sulfate Bone Graft SubstituteParticipants will undergo conventional open reduction and internal fixation. The periarticular bone defect will be filled with calcium sulfate bone graft substitute. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older, regardless of sex.
- Radiographically confirmed proximal humerus fracture, tibial plateau fracture, or distal radius fracture associated with a bone defect and requiring surgical treatment.
- Willing to participate in the clinical trial and able to provide written informed consent.
Key exclusion criteria (7 listed)
- Active systemic infection or active infection at the planned surgical site that may interfere with surgery.
- Pathological fracture, compartment syndrome, osteomyelitis, or severe soft-tissue, vascular, or nerve injury.
- History of allergy or hypersensitivity to magnesium alloy or titanium alloy implant materials.
- Psychiatric illness, inability to comply with study procedures for any reason, or unwillingness or inability to comply with required activity restrictions.
- Drug abuse or alcohol abuse, or inability to refrain from smoking during fracture healing.
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 |
|---|---|---|
| Magnesium Alloy ScaffoldA customized biodegradable magnesium alloy scaffold with controlled degradation will be implanted into the periarticular bone defect during open reduction and internal fixation to provide structural support and facilitate bone healing. | Device | Magnesium Alloy Scaffold Group |
| Calcium Sulfate Bone Graft SubstituteCalcium sulfate granules will be used to fill the periarticular bone defect during conventional open reduction and internal fixation. | Device | Calcium Sulfate Group |
Primary outcome
Bone Union Rate
Time frame: 48 weeks after surgery
Bone union will be considered achieved when both of the following criteria are met: (1) no local tenderness or axial percussion pain and no abnormal mobility at the fracture site; and (2) imaging demonstrates continuous callus or trabecular bone crossing the fracture line, with the fracture line becoming indistinct. The outcome will be reported as the percentage of participants meeting both criteria.
9 secondary outcomes
Barthel Index Score for Activities of Daily Living
Time frame: 4, 8, 12, 24, and 48 weeks after surgery
Patient-Rated Wrist Evaluation (PRWE) Score
Time frame: 4, 8, 12, 24, and 48 weeks after surgery
Hospital for Special Surgery (HSS) Knee Score
Time frame: 4, 8, 12, 24, and 48 weeks after surgery
American Shoulder and Elbow Surgeons (ASES) Score
Time frame: 4, 8, 12, 24, and 48 weeks after surgery
Constant-Murley Shoulder Score
Time frame: 4, 8, 12, 24, and 48 weeks after surgery
Incision Healing Grade
Time frame: 4 and 8 weeks after surgery
Number of Participants Meeting All Four Device Performance Criteria
Time frame: Day of surgery
Distribution of Participants by CT-Assessed Magnesium Alloy Scaffold Degradation Grade at Week 24
Time frame: 24 weeks after surgery
Distribution of Participants by CT-Assessed Magnesium Alloy Scaffold Degradation Grade at Week 48
Time frame: 48 weeks after surgery
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 30 Oct 2026.
- Background: PubMed 37859690Liu B, Liu J, Wang C, Wang Z, Min S, Wang C, Zheng Y, Wen P, Tian Y. High temperature oxidation treated 3D printed anatomical WE43 alloy scaffolds for repairing periarticular bone defects: In vitro and in vivo studies. Bioact Mater. 2023 Oct 11;32:177-189. doi: 10.1016/j.bioactmat.2023.09.016. eCollection 2024 Feb.
- 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.
Yun Tian, MD principal investigator
Peking University Third Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Alloy Scaffold and Calcium Sulfate Bone Graft Substitute in people with Periarticular Bone Defect and Proximal Humerus Fracture, run by Peking University Third Hospital at 4 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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Yiyuan Yang, MD (17812197005, yangyiyuan0612@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Union Rate (time frame: 48 weeks after surgery). 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 NCT07906730, which also lists 1 linked publication.
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 30 Oct 2026.