Walker vs Wheeled Device for Total Knee Replacement

Overseen By Derek Amanatullah, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Not receiving total knee arthroplasty

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

24 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

How does the A-Linker treatment differ from other treatments for total knee replacement?

The A-Linker is a unique mobility device that offers an alternative to traditional walkers or wheeled devices by allowing users to remain upright and active, which may enhance mobility and reduce perceived exertion during recovery from total knee replacement surgery. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals who are undergoing total knee replacement surgery. It's designed to see if a new mobility tool, the A-Linker, helps patients move around better than the usual walker does after their surgery.

Inclusion Criteria

I am scheduled for or have had a total knee replacement.

Timeline

Pre-surgery Preparation

Participants are randomized into two groups and use either an A-linker or a walker for 3 months before surgery

12 weeks

Initial visit for randomization

Surgery

All participants undergo total knee arthroplasty surgery

1 day

Surgery day

Post-surgery Follow-up

Participants are monitored for mobility and pain using various assessments including MyPhD linked wearable device and VAS pain scale

6 months

Assessments at discharge, 2 weeks, 3 months, and 6 months

Treatment Details

Interventions

• A-Linker

Trial Overview The study is testing a novel mobility device called the A-Linker against the standard care walker in patients recovering from knee replacement surgery. The focus is on how well each tool aids in maneuverability and overall mobility post-operation.

Participant Groups

Group I: 1 Experimental Treatment 1 Intervention

1. 12 patients get an A-linker 3 months before surgery (knee arthroplasty)

Group II: 2 Active Control 1 Intervention

2. 12 patients use a walker 3 months before surgery (knee arthroplasty)

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

Patients using a front-wheeled walker after total knee replacement (TKR) surgery demonstrated faster walking velocity and longer step lengths immediately after surgery compared to those using a standard walker, indicating a potential short-term benefit in mobility.

However, by six weeks post-surgery, both walker groups showed similar improvements in walking speed and endurance, suggesting that while the wheeled walker may aid initial recovery, it does not lead to greater long-term ambulation benefits or reduced therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of assistive device prescription on gait following total knee replacement. Pasquini, SM., Peterson, ML., Rattansi, SM., et al.[2010]

In a study involving 24 healthy volunteers, the wheeled knee walker was found to allow for better assisted ambulation compared to axillary crutches, as indicated by significant improvements in walking distance and self-selected walking velocity during a 6-minute walk test.

Participants reported a lower perceived exertion when using the wheeled knee walker, with 88% preferring it over crutches, suggesting it may be a more comfortable option for rehabilitation after lower extremity surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Study of Assisted Ambulation and Perceived Exertion With the Wheeled Knee Walker and Axillary Crutches in Healthy Subjects. Kocher, BK., Chalupa, RL., Lopez, DM., et al.[2017]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile bearing or fixed bearing? A meta-analysis of outcomes comparing mobile bearing and fixed bearing bilateral total knee replacements. [2014]

2. Germany pubmed.ncbi.nlm.nih.gov

Fixed versus mobile weight-bearing prosthesis in total knee arthroplasty. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Rehabilitation approach in robot assisted total knee arthroplasty: an observational study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The impact of assistive device prescription on gait following total knee replacement. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Comparative Study of Assisted Ambulation and Perceived Exertion With the Wheeled Knee Walker and Axillary Crutches in Healthy Subjects. [2017]