RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use

Study Overview
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Brief Summary
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This is a single-center, prospective, randomized, controlled study of the appliedVR RelieVRx headset in subjects undergoing Total Knee Arthroplasty (TKA). This study will evaluate two primary endpoints - effectiveness of a single use of RelieVRx in the reduction of acute postoperative pain by 20%; and overall effectiveness of RelieVRx as an opioid-sparing intervention, where opioid consumption is reduced by at least 20% over a 90-day postoperative period in the interventional, standard of care (SOC) plus RelieVRx group compared to the control, SOC group.

Detailed Description
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This is a single-center, prospective, randomized, controlled study of the appliedVR RelieVRx headset in subjects undergoing Total Knee Arthroplasty (TKA). Patients will be randomized to one of the two groups after study enrollment, and patients in the test arm will be educated about the device preoperatively to facilitate its use in the acute post-operative period. The goals of VR will be presented in the context of an alternate method of pain control to opioids. This study will evaluate two primary endpoints - effectiveness of a single use of RelieVRx in the reduction of acute postoperative pain by 20%; and overall effectiveness of RelieVRx as an opioid-sparing intervention, where opioid consumption is reduced by at least 20% over a 90-day postoperative period in the interventional, standard of care (SOC) plus RelieVRx group compared to the control, SOC group.

Official Title
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Safety and Effectiveness of Virtual Reality Utilizing RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use

Conditions
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Opioid Use, Arthropathy of Knee, Pain, Postoperative

Intervention / Treatment
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* Device: RelieVRx headset
* Drug: multi-modality pain management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 18 years old Subject is willing and able to read, comprehend, and sign the study informed consent form in English prior to study specific procedure Subject is scheduled for Total Knee Arthroplasty (TKA) surgery Subject has a score of 1-3 based on the American Society of Anesthesiologists Physical Status Classification System Subject attended the pre-op Total Joint Arthroplasty Patient Education class (Proven Recovery Program©) Subject agrees to be enrolled in Force Therapeutics, a web-based, digital rehabilitation and education program Subject has family member or community support during post-surgical recovery period Exclusion Criteria: Diagnosed with chronic pain syndrome Body Mass Index (BMI) ≥ 40 Current tobacco user at time of surgery Uncontrolled sleep apnea Bilateral TKA Current or recent history (in past year) of substance abuse disorder Uncontrolled diabetes (HbA1c ≥ 7.0) 7.8 at time of surgery History of Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT) Currently being treated with blood thinners at time of surgery Diagnosis of Rheumatoid Arthritis (RA) Has Methicillin-resistant Staphylococcus aureus (MRSA) Currently pregnant/breastfeeding or planning to in the next 3 months Comorbidities including neurological, psychosocial, sensory, or other disorders that may impact pain perception Diagnosis of epilepsy, dementia, migraines, or other neurological disorders that may prevent VR usage, and/or other medical conditions predisposed to nausea and dizziness Hypersensitivity to flashing lights or motion Claustrophobia Lack of stereoscopic vision Severe hearing impairment Injury to eyes, face, or neck that prevents comfortable VR usage

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care group<br>Receive standard of care for pain management, do not receive RelieVRx headset | Drug: multi-modality pain management<br>* combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids<br>|
| Experimental: Standard of care + RelieVRx group<br>Receive standard of care for pain management, plus RelieVRx headset | Device: RelieVRx headset<br>* RelieVRx is a virtual reality therapy intended as adjunctive treatment for acute surgical pain<br>Drug: multi-modality pain management<br>* combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute postoperative pain | Visual Analog Pain scale; worst 0-10 best | 90 days | 
| opioid consumption | Morphine Milligram Equivalents (MME) | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-anesthesia care unit length of stay | number of minutes in Post-anesthesia care unit | 1 day | 
| Hospital length of stay | number of days admitted in hospital after surgery | 7 days | 
| Time to initial ambulation | number of hours before patient is weight bearing | 7 days | 
| KOOS Jr. score | short form of knee injury and osteoarthritis outcome score; worst 0 - 100 best | 12 months | 
| Veterans RAND 12 Health Survey (VR-12) physical component score | patient's overall perspective of their physical health; worst 15 - 63 best | 12 months | 
| Number of surgical complications | Surgical complications, such as infection or delayed healing | 12 months | 
| Clinic and emergency department visits | Number of unscheduled clinic and emergency department visits | 12 months | 
| Inpatient readmissions for uncontrolled pain | Number of inpatient readmissions for uncontrolled pain | 12 months |