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Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Sponsor: Comeback Mobility Inc
Summary
This study will compare two approaches to rehabilitation after surgery for a fracture of the upper part of the shinbone that involves the knee joint (tibial plateau fracture). The main question is whether a personalized plan for putting weight on the injured leg, combined with feedback from smart crutch tips, helps patients return to walking without assistance sooner than usual care, without increasing complications. Participants will be assigned by chance to one of two groups: * Personalized rehabilitation: Researchers will use CT and MRI scans taken after surgery to create a computer model of the repaired bone and estimate how it responds to different loads. The treating doctor will use this information, together with the patient's clinical condition, to prescribe how much weight the patient may place on the injured leg. Smart Crutch Tips will provide feedback to help the patient follow this prescription. * Usual care: The treating doctor will prescribe weight-bearing according to usual clinical practice. Participants will also use Smart Crutch Tips, but the devices will record information without showing the patient loading data, step counts, or related alerts. Researchers will compare how long it takes participants to walk independently without crutches, a cane, or another walking aid. They will also assess bone healing, knee function, pain, swelling, fear of movement, adherence to weight-bearing instructions, and complications. Participants will attend follow-up visits and complete assessments of their recovery. Imaging specialists who do not know which treatment group participants are in will assess fracture healing and whether the repaired bone has remained in position.
Official title: Individualized Postoperative Weight-Bearing Based on Finite Element Analysis and Smart Crutch Tips Biofeedback in Patients With Intra-Articular Fractures of the Proximal Tibia
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
86
Start Date
2026-11-15
Completion Date
2028-11-30
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Crutch Tip Biofeedback System
Smart Crutch Tips are attached to the participant's crutches or cane to record loading and steps. The system shows loading and step counts and alerts the participant when loading is outside the range prescribed by the treating physician. Participants are trained to use the system and walk safely. Device settings are updated whenever the physician changes the prescribed loading range.
Individualized FEA-Guided Postoperative Weight-Bearing
Patient-specific finite element analysis (FEA) uses CT and MRI obtained 4-14 days after plate fixation to formulate a loading recommendation, considering fixation component stresses and safety factors, interfragmentary displacements, and mechanical conditions at the fracture site. At week 3 (±7 days), the treating physician prescribes loading based on the FEA recommendation and clinical findings. Loading is expressed as a percentage of body weight. The physician may adjust the prescription during rehabilitation based on clinical status and follow-up radiographs. At week 16, CT is used to assess fragment position and repeat FEA accounting for changes at the fracture site. The physician determines subsequent loading and whether restrictions can be lifted.
Usual-Care Postoperative Weight-Bearing
The treating physician prescribes no weight-bearing on the operated limb for 6-12 weeks after plate fixation. The duration of restrictions and subsequent loading progression are based on clinical status and follow-up radiographs. Smart Crutch Tips record loading and steps with biofeedback, alerts, and patient-facing loading information and step counts disabled. Recorded loading data and FEA are not used to guide weight-bearing prescriptions.