Does Weightbearing Crutch Technology Impact Patient Compliance?

A Randomized, Parallel, Two Arm, Unblinded Single-center Study of the Effects of Patient-provided Feedback on Fracture Healing and Weight-bearing Status in Orthopedic Patients Undergoing Operative Fixation or Non-operative Treatment of Isolated Tibial Plateau, Pilon, and Other Ankle Fractures

The goal of this study is to determine if weight-bearing crutch technology that delivers active feedback to patients during their treatment will impact patient compliance with physician instructions.

The weight-bearing tracking system is attached to the patient's crutch and calculates how much weight is being put on the crutch. Feedback of this data can be delivered to the patient through a mobile phone application. For Arm A of the study, feedback is delivered to the patient's paired mobile phone, providing them information on how much weight they are exerting on their crutch/injured lower extremity.

The weight-bearing tracking system is attached to the patient's crutch and calculates how much weight is being put on the crutch. For Arm B, no feedback about weight-bearing status is delivered to the patient.

Feedback on how much weight patients are exerting on their crutch/injured lower extremity (measured via Smart Crutch Tip) will be delivered to their mobile phones.

The device is attached to the crutch and measures how much weight-bearing load is exerted onto its axis. The device is capable of transmitting this data into the patient and physicians' user interface.

Participants rate pain using a VAS ranging from 0 (no hurt) to 10 (unbearable pain). A decrease in scores indicates pain decreased during the observational period.

Inclusion Criteria: Willing and able to participate in study and complete consent Will undergo treatment of an isolated tibial plateau, pilon, or ankle fracture and placed in a non-weightbearing status with the use of crutches at NYU. Have access and use of a mobile phone (exclusively iOS and/or Android devices) Exclusion Criteria: Patients with concomitant TBI Polytrauma patients Pathologic fractures Prisoners

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [joseph.robin@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

The investigator who proposed to use the data will be granted access upon reasonable request. equests should be directed to joseph.robin@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.