Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT07138066
Description:
Time to radiographic fracture union (primary endpoint)
mRUST scores at predefined time points
Compliance data on axial loading collected by Smart Crutch Tips™
Functional recovery outcomes (LEFS, TSK-17 questionnaire responses)
Pain level assessments (VAS)
Adverse event data, including AEs, SAEs, ADEs, SADEs, and device deficiencies
Gait adherence metrics derived from the CBM mobile app
Baseline demographic and clinical information relevant to fracture type and healing (e.g., fracture classification, BMI, CT-derived FEA data)
Study:
NCT07138066
Study Brief:
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures