Observation of Wheeled Device Use After TKA

NCT06080152 | Recruiting

• 1 other identifier: 70192
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Mobility after surgery

  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.

  6 months

Secondary Outcomes (5)

• Determining intensity of pain

  6 months

• Change in knee society score

  6 months

• surgery cancellation

  6 months

• Use of gait aide

  6 months

• Time with Device

  6 months

Study Arms (1)

1

EXPERIMENTAL

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

Device: Mobility Tool

Interventions

Mobility Tool DEVICE

An A-Linker device will be given to 12 patients 3 months before their total knee arthroplasty

1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any person receiving Primary Total Knee Arthroplasty, ages 18-99
• Patient is mobile with no more than a single cane/single crutch assist preoperatively

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

450 Broadway

Redwood City, California, 94063, United States

RECRUITING

Central Study Contacts

Derek Amanatullah, MD

CONTACT

(650) 723-2257; DFA@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedic Surgery

Model Details: 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

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: October 12, 2023
• Study Start: October 2, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (1)