Trial · NCT07906730
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
NCT07906730, Not applicable, Not yet recruiting, Peking University Third Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects. Trials, record NCT07906730. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07906730
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
- NCT number
- NCT07906730
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 120 participants, estimated
- Lead sponsor
- Peking University Third Hospital
- Conditions
- Periarticular Bone Defect, Proximal Humerus Fracture, Distal Radius Fracture, Tibial Plateau Fracture
- Interventions
- Magnesium Alloy Scaffold, Calcium Sulfate Bone Graft Substitute
- First posted
- 2026-10-30
- Last updated
- 2026-10-30
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bone Union Rate | 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. |
| Secondary | Barthel Index Score for Activities of Daily Living | 4, 8, 12, 24, and 48 weeks after surgery | 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. |
| Secondary | Patient-Rated Wrist Evaluation (PRWE) Score | 4, 8, 12, 24, and 48 weeks after surgery | 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. |
| Secondary | Hospital for Special Surgery (HSS) Knee Score | 4, 8, 12, 24, and 48 weeks after surgery | 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. |
| Secondary | American Shoulder and Elbow Surgeons (ASES) Score | 4, 8, 12, 24, and 48 weeks after surgery | 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. |
| Secondary | Constant-Murley Shoulder Score | 4, 8, 12, 24, and 48 weeks after surgery | 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. |
| Secondary | Incision Healing Grade | 4 and 8 weeks after surgery | Incision healing will be classified as Grade A (good healing), Grade B (suboptimal healing), or Grade C (purulent wound healing). |
| Secondary | Number of Participants Meeting All Four Device Performance Criteria | Day of surgery | 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. |
| Secondary | Distribution of Participants by CT-Assessed Magnesium Alloy Scaffold Degradation Grade at Week 24 | 24 weeks after surgery | 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. |
| Secondary | Distribution of Participants by CT-Assessed Magnesium Alloy Scaffold Degradation Grade at Week 48 | 48 weeks after surgery | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37859690 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07906730
GET https://conductscience.org/api/trials/v1/NCT07906730/registered