Smart Glasses for Total Knee Replacement

(SMART Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Disqualifiers: Local infection, BMI >40, Nerve damage, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how smart glasses, a wearable device, might improve a specific type of nerve block used during total knee replacement surgery compared to the usual method. The goal is to determine if these glasses can enhance or simplify the procedure. The trial seeks participants planning to undergo total knee replacement who do not have certain health issues, such as a body mass index (BMI) over 40 or nerve damage in the leg.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance surgical procedures.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these smart glasses are safe for use in saphenous nerve adductor canal blocks?

Research has shown that using smart glasses in knee surgery is generally safe. One study found these glasses to be as accurate as robotic systems, making them reliable during surgery. Another study discovered that this technology enhances doctors' ability to see and align elements during operations by using special codes and 3D images.

Although these tools are safe, some risks exist. For instance, some patients have reported dissatisfaction with their results after surgery, though this is not directly related to the smart glasses. Overall, studies indicate that the use of smart glasses is well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about smart glasses for total knee replacement because they bring cutting-edge technology to the operating room. Unlike traditional methods that rely solely on the surgeon's experience and static imaging, smart glasses provide real-time, augmented reality overlays, helping surgeons visualize the knee anatomy with enhanced precision. This innovative approach aims to improve surgical accuracy, potentially leading to better outcomes, faster recovery times, and reduced complications for patients undergoing knee replacement surgery.

What evidence suggests that smart glasses are effective for saphenous nerve adductor canal blocks?

Research has shown that smart glasses, which participants in this trial may use, can enhance the precision of knee surgeries. Studies have found that augmented reality (AR) technology, such as smart glasses, increases surgeons' accuracy during total knee replacement surgeries. This improvement can lead to better patient outcomes and more consistent results. Additionally, virtual reality-based rehabilitation, using similar technology, effectively reduces pain and improves movement after knee surgery. These findings suggest that smart glasses could be a promising tool for enhancing both surgery and recovery in knee procedures. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having a total knee replacement. It's not suitable for pregnant women, prisoners, those with nerve damage in the leg area, mental or cognitive disabilities, local infection where the block goes, very high BMI (>40), risk of anesthesia toxicity, or if they can't communicate in English.

Inclusion Criteria

I am scheduled for total knee replacement surgery.

I am 18 years old or older.

Exclusion Criteria

Pregnant women (self-reported)

Prisoners

Patients with nerve damage to the femoral or saphenous nerve

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive saphenous nerve adductor canal blocks using smart glasses or standard of care

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Smart Glasses

Trial Overview The study is testing how well smart glasses work when doctors use them to perform nerve blocks in the thigh area (saphenous nerve adductor canal block) compared to the usual method without smart glasses during knee surgery.

How Is the Trial Designed?

Group I: Smartglasses Experimental Treatment 1 Intervention

Group II: Standard of care Active Control 1 Intervention

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12584369/

Smart device–assisted telerehabilitation versus conventional ... Total knee arthroplasty (TKA) is the gold standard for treating end-stage knee osteoarthritis (OA). Due to its outstanding clinical efficacy, it ...

2. asj.amegroups.org asj.amegroups.org/article/view/97079/html

Augmented reality in knee arthroplasty: a scoping review of ... Conclusions: AR technology shows promise in improving surgical precision and reducing variability in TKA. However, challenges such as study ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352344124002504

Accuracy of a New Augmented Reality Assisted Technique ... Simpson, G.J. Macpherson, et al. Robotic-arm assisted total knee arthroplasty is associated with improved accuracy and patient reported outcomes: a systematic ...

4. bfpt.springeropen.com bfpt.springeropen.com/articles/10.1186/s43161-024-00246-y

Efficacy of virtual reality-based rehabilitation following total ... Immersive and non-immersive VRBR are effective following TKR. The effect on pain and function may be sustained over three or six months.

5. ijoro.org ijoro.org/index.php/ijoro/article/download/3079/1729/16557

Pixee knee+ augmented reality assisted navigation for total ... In total knee arthroplasty (TKA), accurate alignment is essential to favorable post-operative outcomes as well as.

6. isakos.com isakos.com/GlobalLink/Abstract/7786

Soft Tissue Safety In Robotic-Assisted Total Knee ... Soft tissue injuries, particularly in the posterior compartment, were observed, with a 68.9% injury rate. Despite the increased damage from expanded margins, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12179877/

Augmented reality in total knee arthroplasty - PubMed Central However, An average rate of 10% to 20% of patients remain partially dissatisfied with their postoperative outcomes[3,4]. Integrating AR into ...

8. kneesurgrelatres.biomedcentral.com kneesurgrelatres.biomedcentral.com/articles/10.1186/s43019-025-00295-0

Artificial intelligence in total knee arthroplasty: clinical ... Pixee Medical employs QR code markers and smart glasses to generate intraoperative 3D coordinate systems, aiding real-time alignment and ...