Trial · NCT07906730
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Other | Number of Participants With at Least One Adverse Event | From the preoperative assessment through 48 weeks after surgery. | 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. |
| Other | Number of Participants With at Least One Serious Adverse Event | From the preoperative assessment through 48 weeks after surgery. | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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