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OpenTrials
Completed

NCT Number: NCT05825079

Does Weightbearing Crutch Technology Impact Patient Compliance?

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.

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Key information

Conditions

Fracture Healing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight-Bearing Feedback

Behavioral

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.

Smart Crutch Tip

Device

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.

Primary outcomes

  1. Percent (%) Change in Average Weight On Crutch from Week 2 to Week 12

    Time frame: Week 2, Week 12

    Average weight put on crutch measured using the Smart Crutch Tip.

Secondary outcomes

  1. Time to Recovery

    Time frame: Up to Week 12

    Measured as the duration of time from treatment (operative or non-operative) to recovery.

  2. Change in Visual Analogue Scale (VAS) - Pain Score from Baseline to Week 12

    Time frame: 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.

  3. Percent (%) of Participants with Injury Complications

    Time frame: Up to Week 12

  4. Percent (%) of Participants who Experience Nonunion/Malunion of Lower Extremity Injury

    Time frame: Up to Week 12

    Nonunion/malunion assessed using radiographic imaging.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • ComeBack Mobility

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2023
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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