Total Knee Arthroplasty
Conditions
Brief summary
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.
Detailed description
Individuals living with challenges that affect their mobility may lead to loss of independence, loss of activity and engagement with life. We are seeking individuals who are having a Total Knee Replacement and are seeking increased mobility using the Alinker, which is a non-motorized walking bike without pedals. Each participant will receive the Alinker prior to surgery, and will be encouraged to use it as much as possible before surgery and during the 3-month post-operative period.
Interventions
DEVICEMobility Tool
An A-Linker device will be given to 12 patients 3 months before their total knee arthroplasty
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Each participant will receive the Alinker prior to surgery, and will be encouraged to use it as much as possible before surgery and during the 3-month post-operative period. A maximum of 19 patients will be enrolled and will receive an Alinker prior to surgery at their pre-op clinical visit. The Alinker will be assembled with a bicycle odometer to track usage and mobility. The odometer will be checked 2 weeks, 6 weeks, and 3 months after surgery during a post-op clinical exam. The participant will answer questionnaires pre-operatively and at 2 weeks, 6 weeks, and 3 months. Questionnaires at: * Pre-operatively * 2 weeks post-operatively * 6 weeks post-operatively * 12 weeks post-operatively
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Any person receiving Primary Total Knee Arthroplasty, ages 18-99 * Patient is mobile with no more than a single cane/single crutch assist preoperatively
Exclusion criteria
* Any person not receiving knee arthroplasty, ages under 18 or greater than 99 * Patient requires simultaneous or staged bilateral replacements, staged \<90 days apart. * Patients who have active claudication from a lumbar stenosis or peripheral vascular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mobility after surgery | 6 months | Mobility will be assessed by using a bicycle odometer to track usage and mobility. The odometer will be checked 2 weeks, 6 weeks, and 3 months after surgery during a post-op clinical exam. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of gait aide | 6 months | 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 |
| Time with Device | 6 months | Determining compliance of device usage |
| Determining intensity of pain | 6 months | We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain |
| Change in knee society score | 6 months | 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 |
| surgery cancellation | 6 months | To determine if surgery was cancelled as a result of effectiveness of device |
Countries
United States
Contacts
CONTACTDerek Amanatullah, MD
Outcome results
None listed