Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia 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 extra-articular distal 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.
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.
Diagnosed with a closed tibial shaft fracture (AO/OTA classification: 43- А1, 43-А2, 43-А3) requiring surgical treatment.
Disqualifiers
Presence of open or high-energy fractures, multiple lower-limb fractures, or use of bone grafts.
Fractures classified as 41-A, 41-B, or 42 -A,B 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
- Orthopedic shoes for use during rehabilitation period
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov