Status:
COMPLETED
RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use
Lead Sponsor:
AppliedVR Inc.
Collaborating Sponsors:
Geisinger Clinic
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Use
Arthropathy of Knee
Eligibility:
All Genders
18+ years
Phase:
NA
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 endpoint...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04010266
Start Date
March 1 2021
End Date
August 31 2023
Last Update
February 14 2024
Active Locations (3)
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1
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
2
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
3
Geisinger South Wilkes Barre
Wilkes-Barre, Pennsylvania, United States, 18765