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Clinical Trials/NCT06080152
NCT06080152
Recruiting
N/A

Observation of Wheeled Device Use After TKA

Stanford University1 site in 1 country19 target enrollmentOctober 2, 2024

Overview

Phase
N/A
Intervention
Mobility Tool
Conditions
Total Knee Arthroplasty
Sponsor
Stanford University
Enrollment
19
Locations
1
Primary Endpoint
Mobility after surgery
Status
Recruiting
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2, 2024
End Date
August 1, 2028
Last Updated
last month
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Derek Amanatullah

Associate Professor of Orthopaedic Surgery

Stanford University

Eligibility Criteria

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

Arms & Interventions

1

19 patients get an A-linker 1-3 months before surgery (knee arthroplasty)

Intervention: Mobility Tool

Outcomes

Primary Outcomes

Mobility after surgery

Time Frame: 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 Outcomes

  • Change in knee society score(6 months)
  • surgery cancellation(6 months)
  • Use of gait aide(6 months)
  • Determining intensity of pain(6 months)
  • Time with Device(6 months)

Study Sites (1)

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