Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorComeback Mobility Inc
About this trial
The goal of this clinical trial is to learn whether personalized weight-bearing prescriptions using Smart Crutch Tips™ can improve recovery after surgery for tibial shaft 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? Does iterative walking in the early postoperative period support faster or better bone healing? Researchers will compare standard rehabilitation to different types of personalized weight-bearing programs to see which 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 six follow-up visits over 36 weeks for clinical exams, x-rays, and CT scans; Complete online questionnaires about pain, activity, and fear of movement.
Eligibility criteria
Qualifiers
Signed informed consent was provided after being fully informed about participation in the study.
Age: 18 to 80 years for both males and females (pre-menopausal).
Body weight between 40 and 120 kg.
Body Mass Index (BMI) between 18.5 and 29.9 kg/m².
Disqualifiers
Presence of open or high-energy fractures, multiple lower-limb fractures, or use of bone grafts.
Fractures classified as 43-B or 43-C according to AO/OTA.
Chronic alcoholism (defined as >14 standard drinks per week for men or >7 for women).
Presence of metabolic disorders, including uncontrolled thyroid dysfunction, severe renal or hepatic pathology.
Trial design
Treatments tested in this trial
- Smart Crutch Tips™
- Finite Element Analysis (FEA)
- Iterative walking
- Lower Limb Rehabilitation Exercise Program
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov