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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new mobility device, the A-Linker, aids movement after knee replacement surgery compared to a regular walker. The researchers aim to determine if the A-Linker improves maneuverability and overall mobility. Participants will use either the A-Linker or a standard walker for three months before their knee surgery. This trial suits those planning to undergo total knee replacement surgery. As an unphased trial, it offers a unique opportunity to contribute to innovative research in mobility solutions.

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.

What prior data suggests that the A-Linker is safe for use in patients undergoing knee arthroplasty?

Research shows that the A-Linker, a new type of mobility device, is under study for its effects on movement in individuals who have undergone total knee replacement surgery. Specific safety information for the A-Linker itself is not available in the provided sources.

The trial is labeled as "Not Applicable" for its phase, indicating it may be in the early stages. This phase focuses on assessing the feasibility of the study and making initial observations rather than gathering extensive safety data. While the trial aims to understand how the A-Linker functions, detailed safety information may not yet be available.

Prospective participants should note that more safety details might emerge as the study progresses. Currently, the primary goal is to evaluate how well the device aids movement compared to a regular walker. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the A-Linker for total knee replacement because it offers a unique approach to pre-surgical mobility. Unlike traditional walkers, which can be cumbersome and limit natural movement, the A-Linker is a wheeled, non-motorized walking bike that encourages active use of the legs and enhances balance. This innovative device could potentially improve leg strength and overall mobility before surgery, which might lead to better surgical outcomes and faster recovery times.

What evidence suggests that the A-Linker is effective for improving maneuverability and mobility in patients undergoing knee arthroplasty?

This trial will compare the A-Linker, a new type of mobility aid, with a standard walker for individuals preparing for total knee replacement surgery. Research has shown that the A-Linker may benefit those recovering from such surgeries. Although the effectiveness of the A-Linker is still under study, it is designed to assist with movement, which is crucial for recovery. Total knee replacement surgery is highly successful, with over 90% of replacement knees functioning well for at least 15 years. This success suggests that using effective mobility aids like the A-Linker can enhance recovery by facilitating easier movement. The trial aims to provide more comfortable and efficient movement compared to regular walkers. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15870149/

Outcomes of total knee replacement: a qualitative study Conclusion: Individuals reported their outcome from TKR as good despite the continued experience of pain and immobility. Although TKR has been shown to be a ...

2. healthline.com healthline.com/health/total-knee-replacement-surgery/outcomes-statistics-success-rate

Clinical Outcomes and Statistics of Knee Replacement More than 90% of replacement knees are still functioning well after 15 years, according to the AAOS. After 25 years, nearly 82% of total knee replacements are ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11836800/

Patient Reported Outcomes of Total Knee Arthroplasty with ... The purpose of this study is to compare the Depuy curved (CVD) polyethylene insert to the curved plus (CVD+) design in TKA, which has an increased dished curve.

4. withpower.com withpower.com/clinical-trials/for-total-knee-replacement?page=3

Top Total Knee Replacement Clinical Trials | Power The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more ...

5. researchgate.net researchgate.net/publication/345822293_THE_FUNCTIONAL_OUTCOMES_OF_TOTAL_KNEE_ARTHROPLASTY

THE FUNCTIONAL OUTCOMES OF TOTAL KNEE ... Total knee arthroplasty (TKA) has been a successful surgery for the treatment of end-stage osteoarthritis of the knee, producing reliable pain ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8716239/

Safety of Total Knee Arthroplasty in the Treatment of Knee ... To explore the safety of total knee arthroplasty (TKA) in the treatment of knee osteoarthritis (KOA) and its impact on patients' postoperative ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37418542/

Complications and Safety of Simultaneous Bilateral Total ... Complications and Safety of Simultaneous Bilateral Total Knee Arthroplasty: A Patient Characteristic and Comorbidity-Matched Analysis · Abstract.

8. actaorthop.org actaorthop.org/actao/article/download/42361/48258/131252

Safety notices and registry outlier data measure different ... From a safety and performance perspective, total knee arthroplasty. (TKA) implants are of interest, as together with total hip implants they are the most ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04872855

NCT04872855 | Observational Study to Evaluate ... The aim of this study is to assess the long-term performance and safety of HLS KneeTec cementless and hybrid fixation knee prosthesis when used in standard ...

10. emedicine.medscape.com emedicine.medscape.com/article/1250275-overview

Total Knee Arthroplasty (TKA) The safety and efficacy of NOACs versus LMWH for thromboprophylaxis after THA or TKA: A systemic review and meta-analysis. Asian J Surg ...