Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT07134257
Brief Summary:
The goal of this clinical trial is to learn whether personalized weight-bearing prescriptions using Smart Crutch Tips™ can improve recovery after surgery for extra-articular proximal tibia fractures. The study will also assess how safe and practical this approach is in daily outpatient use.
Can a personalized weight-bearing program based on CT and finite element analysis help the fracture heal faster? Can it help patients return to full weight-bearing sooner? Can it reduce the fear of movement during recovery? Researchers will compare standard rehabilitation, AO Foundation-based recommendations, and personalized weight-bearing programs derived from finite element analysis (FEA) to determine which approach leads to faster healing, earlier mobility, and better outcomes.
Participants will:
Use Smart Crutch Tips™ during walking for up to 24 weeks; Follow a personalized weight-bearing prescription based on CT scans and biomechanical modeling; Follow a specific walking plan with real-time audio and visual feedback; Attend eight follow-up visits over 36 weeks for clinical exams, x-rays, and CT scans; Complete online questionnaires about pain, activity, and fear of movement.
Detailed Description:
This is a pilot multicenter clinical trial designed to explore the impact of individualized weight-bearing regimens and iterative walking protocols on the healing of extra-articular proximal tibia fractures. The study will enroll 30 adult participants (aged 18-60) with closed proximal tibia fractures (AO/OTA 41-A2, 41-A3) treated with plates. Participants will be allocated into three parallel groups (ten participants per group).
Group 1 - Control (Standard Practice):
During the first six weeks, participants will not load the operated leg. After this period, they will gradually increase weight-bearing within pain tolerance. Smart Crutch Tips™ will be used with indicators turned off (data collection only, without feedback).
Group 2 - AO Foundation Recommendations:
Participants will be allowed partial weight-bearing (touchdown or 10-15 kg load) with crutches or walkers according to AO Foundation guidelines. Smart Crutch Tips™ will be used with indicators turned on, providing real-time feedback on loading level.
Group 3 - FEA-Based Personalized Loading:
Participants will receive individualized axial loading prescriptions developed using finite element analysis (FEA). Smart Crutch Tips™ will be used with visual and auditory real-time feedback. In addition to personalized loading, participants will follow an iterative walking protocol. Participants will also perform a set of isometric and dynamic exercises to strengthen the lower limb muscles
Study Objectives:
The primary aim is to determine whether providing precise, data-driven weight-bearing recommendations-delivered via Smart Crutch Tips™ with real-time visual and auditory feedback-can enhance fracture healing by promoting safe interfragmentary motion.
Device Use and Follow-Up:
Participants will use ComeBack Mobility Smart Crutch Tips™ whenever they use crutches in an outpatient setting for up to 24 weeks, depending on their healing progress. These devices provide real-time guidance to help users stay within their prescribed weight-bearing range and transmit data to a centralized monitoring platform.
Participants will attend eight in-person follow-up visits: screening (Day 0-7) and then at 4, 8, 12, 15, 18, 24, and 36 weeks post-surgery. At each follow-up visit starting from Visit 1 (4 weeks), radiographic assessments (X-ray) will be performed to monitor fracture healing. Computed tomography (CT) scans will be conducted at specific time points: during the screening period (0-7 days post-surgery) and prior to Visit 1 (4 weeks), Visit 2 (8 weeks), and optionally before Visit 3 (12 weeks) , to adjust weight-bearing prescriptions and assess consolidation dynamics.
Data Collection:
Clinical data will be collected via the ComeBack Mobility app and electronic case report forms (eCRFs). Before each follow-up visit, participants will complete an online diary that includes validated questionnaires such as the Tampa Scale for Kinesiophobia (TSK-17) and the Lower Extremity Functional Scale (LEFS).
Standardization Across Sites:
All study procedures will follow a standardized research protocol implemented across multiple orthopedic hospitals and trauma centers in Ukraine to ensure consistency in surgical technique, data collection, and follow-up.
Study:
NCT07134257
Study Brief:
Protocol Section:
NCT07134257