Fracture HealingNCT05825079
Does Weightbearing Crutch Technology Impact Patient Compliance?
A study testing Weight-Bearing Feedback and Smart Crutch Tip in people with Fracture Healing, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture Healing
- What is being tested?
- Weight-Bearing Feedback and Smart Crutch Tip
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2023to 28 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients with concomitant TBI
- Polytrauma patients
- Pathologic fractures
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Fracture Healing
- Being tested
- Weight-Bearing Feedback, Smart Crutch Tip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight-Bearing FeedbackBehavioural
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 TipDevice
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 group | Role | What they receive |
|---|---|---|
| Weight-Bearing Feedback Delivered to Mobile Phone | Experimental | 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. Receives: Behavioral: Weight-Bearing Feedback; Device: Smart Crutch Tip |
| No Weight-Bearing Feedback | Active comparator | 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. Receives: Device: Smart Crutch Tip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent (%) Change in Average Weight On Crutch from Week 2 to Week 12
Average weight put on crutch measured using the Smart Crutch Tip.
Measured: Week 2, Week 12
Secondary outcomes (4)
Time to Recovery
Measured as the duration of time from treatment (operative or non-operative) to recovery.
Measured: 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.
Measured: Baseline, Week 12
Percent (%) of Participants with Injury Complications
Measured: Up to Week 12
Percent (%) of Participants who Experience Nonunion/Malunion of Lower Extremity Injury
Nonunion/malunion assessed using radiographic imaging.
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start9 Jun 2023
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture HealingStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- ComeBack Mobility
- Responsible party
- Sponsor
- Investigators
- Kenneth A. Egol, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825079
- Sponsor's protocol ID
- 22-01427
- Status last verified
- Jan 2026
- First submitted
- 11 Apr 2023
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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: Kenneth.Egol@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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05825079
- Acronym / sponsor ID
- 22-01427
- Conditions
- Fracture Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- ComeBack Mobility
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight-Bearing Feedback Delivered to Mobile Phone | Experimental | Behavioral: Weight-Bearing Feedback, Device: Smart Crutch TipThe 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. |
| No Weight-Bearing Feedback | Active comparator | Device: Smart Crutch TipThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- Patients with concomitant TBI
- Polytrauma patients
- Pathologic fractures
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight-Bearing FeedbackFeedback 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. | Behavioural | Weight-Bearing Feedback Delivered to Mobile Phone |
| Smart Crutch TipThe 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. | Device | No Weight-Bearing Feedback, Weight-Bearing Feedback Delivered to Mobile Phone |
Primary outcome
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.
4 secondary outcomes
Time to Recovery
Time frame: Up to Week 12
Change in Visual Analogue Scale (VAS) - Pain Score from Baseline to Week 12
Time frame: Baseline, Week 12
Percent (%) of Participants with Injury Complications
Time frame: Up to Week 12
Percent (%) of Participants who Experience Nonunion/Malunion of Lower Extremity Injury
Time frame: Up to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes. 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: Kenneth.Egol@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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth A. Egol, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight-Bearing Feedback and Smart Crutch Tip in people with Fracture Healing, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent (%) Change in Average Weight On Crutch from Week 2 to Week 12 (time frame: Week 2, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.