Does Weightbearing Crutch Technology Impact Patient Compliance?

Fracture Healing Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05825079
• Other study ID #: 22-01427
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Joseph Robin, MD
• Phone: (205)-908-6889
• Email: Joseph.robin[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fracture Healing
• Fractures, Bone

Intervention

Behavioral:
• Weight-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.

Device:
• Smart 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	ComeBack Mobility

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Recovery	Measured as the duration of time from treatment (operative or non-operative) to recovery.	Up to Week 12
Secondary	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
Secondary	Percent (%) of Participants with Injury Complications		Up to Week 12
Secondary	Percent (%) of Participants who Experience Nonunion/Malunion of Lower Extremity Injury	Nonunion/malunion assessed using radiographic imaging.	Up to Week 12