Does Weightbearing Crutch Technology Impact Patient Compliance?

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Fracture Healing

Intervention / Treatment
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* Behavioral: Weight-Bearing Feedback
* Device: Smart Crutch Tip


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight-Bearing Feedback Delivered to Mobile Phone<br>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. | Behavioral: Weight-Bearing Feedback<br>* 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.<br>Device: Smart Crutch Tip<br>* 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.<br>|
| Active Comparator: No Weight-Bearing Feedback<br>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. | Device: Smart Crutch Tip<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent (%) Change in Average Weight On Crutch from Week 2 to Week 12 | Average weight put on crutch measured using the Smart Crutch Tip. | Week 2, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Recovery | Measured as the duration of time from treatment (operative or non-operative) to recovery. | Up to Week 12 | 
| Change in Visual Analogue Scale (VAS) - Pain Score from Baseline to Week 12 | 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. | Baseline, Week 12 | 
| Percent (%) of Participants with Injury Complications |  | Up to Week 12 | 
| Percent (%) of Participants who Experience Nonunion/Malunion of Lower Extremity Injury | Nonunion/malunion assessed using radiographic imaging. | Up to Week 12 |