Total Knee Arthroplasty Clinical Trial
Official title:
Effect of Walker vs Wheeled Device on Mobility After Total Knee Arthroplasty
NCT number | NCT06080152 |
Other study ID # | 70192 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2024 |
Est. completion date | August 2025 |
Verified date | April 2024 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Maneuverability is currently under appreciated by patients who are seeking mobility. This pilot study is examining how patients maneuverability and mobility will change with this novel mobility tool - A-Linker compared to the standard of care walker.
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | August 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Receiving total knee arthroplasty Exclusion Criteria: - Not receiving total knee arthroplasty |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mobility after surgery | Mobility will be assess using MyPhD linked wearable device. The software will help us capture-
Steps: # of steps per hour Walking/Running distance: per hour |
6 months | |
Secondary | Questionnaire Results | Mobility will be assess using MyPhD linked wearable device. The software will help us capture-
Steps: # of steps per hour Walking/Running distance: per hour |
6 months | |
Secondary | Determining intensity of pain | We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain | 6 months | |
Secondary | Change in knee society score | To assess the effectiveness of the device by calculating Initial knee society score (KSS) and Knee society score at 2 weeks, 3 months and 2 years after surgery. The scale ranges from 0-100 with grading as Score 80-100 - Excellent Score 70-79 - Good Score 60-69 - Fair Score below 60 - Poor | 6 months | |
Secondary | surgery cancellation | To determine if surgery was cancelled as a result of effectiveness of device | 6 months | |
Secondary | Timed up & Go | Calculating Timed up & Go at 6 months visit | 6 months | |
Secondary | Use of gait aide | To assess the effectiveness of the device by examining Gait Aide use at discharge, 2 weeks, 3 months and 2 years after surgery. This is done to examine performance . The gait aide use provident ranges as Nothing > Cane > crutch > walker | 6 months | |
Secondary | Time with Device | Determining compliance of device usage | 6 months |
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