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Clinical Trials/NCT05825079
NCT05825079
Completed
Not Applicable

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

NYU Langone Health1 site in 1 country20 target enrollmentStarted: June 9, 2023Last updated:
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ConditionsFracture Healing

Overview

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Percent (%) Change in Average Weight On Crutch from Week 2 to Week 12
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Change in Visual Analogue Scale (VAS) - Pain Score from Baseline to Week 12(Baseline, Week 12)
  • Time to Recovery(Up to Week 12)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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