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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05825079

Enrollment

Registered

2023-04-24

Start date

2023-06-09

Completion date

2025-07-28

Last updated

2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture Healing

Brief summary

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.

Interventions

BEHAVIORALWeight-Bearing Feedback

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.

DEVICESmart Crutch Tip

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026