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

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AppliedVR Inc.
• Collaborator: Geisinger Clinic

Criteria

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