An interventional study of Magnesium Alloy Scaffold and Calcium Sulfate Bone Graft Substitute in Periarticular Bone Defect, Proximal Humerus Fracture and Distal Radius Fracture, sponsored by Peking University Third Hospital. Not yet recruiting at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment
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.
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.
331 studies on the registry are indexed under Wrist Fractures; 71 are open to participants now.
This study's planned enrollment of 120 is above the median of 64 across 269 interventional studies indexed under Wrist Fractures.
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Exclusion Criteria:
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.
Device: Magnesium Alloy Scaffold
Participants will undergo conventional open reduction and internal fixation. The periarticular bone defect will be filled with calcium sulfate bone graft substitute.
Device: Calcium Sulfate Bone Graft Substitute
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 granules will be used to fill the periarticular bone defect during conventional open reduction and internal fixation.
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.
Time frame: 48 weeks after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 48 weeks after surgery
Number of Participants With at Least One Adverse Event
Adverse events (AEs) will be monitored throughout the study, regardless of their relationship to the investigational device or study procedure. The number and percentage of participants experiencing at least one adverse event will be reported for each treatment group. Each participant will be counted only once, regardless of the number of events experienced. Event type, onset, severity, management, relationship to the device or procedure, duration, and outcome will be documented.
Time frame: From the preoperative assessment through 48 weeks after surgery.
Number of Participants With at Least One Serious Adverse Event
Serious adverse events (SAEs) will be monitored throughout the study, regardless of their relationship to the investigational device or study procedure. The number and percentage of participants experiencing at least one serious adverse event will be reported for each treatment group. Each participant will be counted only once, regardless of the number of serious adverse events experienced. Event type, onset, severity, management, relationship to the device or procedure, duration, and outcome will be documented.
Time frame: From the preoperative assessment through 48 weeks after surgery.
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Plan to share: No
Start is estimated for Nov 2026; primary completion for Jun 2028, 19 months later.
Of 120 non-industry interventional studies with no phase under Wrist Fractures, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 50. This study's planned 19 months is below that.
Counting every sponsor, half of 121 studies reached it within 26 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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