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

Not Applicable

Completed

• Conditions: Arthropathy of Knee; Pain, Postoperative; Opioid Use
• Interventions: Device: RelieVRx headset; Drug: multi-modality pain management

• Registration Number: NCT04010266
• Lead Sponsor: AppliedVR Inc.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-08
• Study Start: 2021-03-01
• Primary Completion: 2022-08-31
• Study Completion: 2023-08-31
• Results First Submitted: 2023-11-23
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-10
• Last Update Submitted: 2024-02-10
• Results First Posted: 2024-02-14
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

1. Subject is ≥ 18 years old
2. Subject is willing and able to read, comprehend, and sign the study informed consent form in English prior to study specific procedure
3. Subject is scheduled for Total Knee Arthroplasty (TKA) surgery
4. Subject has a score of 1-3 based on the American Society of Anesthesiologists Physical Status Classification System
5. Subject attended the pre-op Total Joint Arthroplasty Patient Education class (Proven Recovery Program©)
6. Subject agrees to be enrolled in Force Therapeutics, a web-based, digital rehabilitation and education program
7. Subject has family member or community support during post-surgical recovery period

Exclusion Criteria

1. Diagnosed with chronic pain syndrome
2. Body Mass Index (BMI) ≥ 40
3. Current tobacco user at time of surgery
4. Uncontrolled sleep apnea
5. Bilateral TKA
6. Current or recent history (in past year) of substance abuse disorder
7. Uncontrolled diabetes (HbA1c ≥ 7.0) 7.8 at time of surgery
8. History of Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT)
9. Currently being treated with blood thinners at time of surgery
10. Diagnosis of Rheumatoid Arthritis (RA)
11. Has Methicillin-resistant Staphylococcus aureus (MRSA)
12. Currently pregnant/breastfeeding or planning to in the next 3 months
13. Comorbidities including neurological, psychosocial, sensory, or other disorders that may impact pain perception
14. Diagnosis of epilepsy, dementia, migraines, or other neurological disorders that may prevent VR usage, and/or other medical conditions predisposed to nausea and dizziness
15. Hypersensitivity to flashing lights or motion
16. Claustrophobia
17. Lack of stereoscopic vision
18. Severe hearing impairment
19. Injury to eyes, face, or neck that prevents comfortable VR usage

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care + RelieVRx group	RelieVRx headset	Receive standard of care for pain management, plus RelieVRx headset
Standard of care + RelieVRx group	multi-modality pain management	Receive standard of care for pain management, plus RelieVRx headset
Standard of care group	multi-modality pain management	Receive standard of care for pain management, do not receive RelieVRx headset

Primary Outcome Measures

Name	Time	Method
Acute Postoperative Pain	90 days	Visual Analog Pain scale; worst 0-10 best
Opioid Consumption	90 days	Morphine Milligram Equivalents (MME)

Secondary Outcome Measures

Name	Time	Method
KOOS Jr. Score	90 days	short form of knee injury and osteoarthritis outcome score; worst 0 - 100 best
Veterans RAND 12 Health Survey (VR-12) - Physical Component Score	90 days	This is a measure of quality of life. The VR-12 provides a physical component score (i.e., physical health domain) that provides larger weights for four of the domains (physical function, role-physical, bodily pain, and general health). This is a 12 items survey. VR-12 scores are standardized using a T-score metric with a mean of 50 and a standard deviation of 10. Larger values imply greater physical function and quality of life.

Trial Locations

Locations (3)

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

Geisinger Wyoming Valley Medical Center; 🇺🇸 Wilkes-Barre, Pennsylvania, United States

Geisinger South Wilkes Barre; 🇺🇸 Wilkes-Barre, Pennsylvania, United States