Can the Use of Virtual Reality Improve TKA Outcomes (VR-TKA)

April 29, 2025 updated by: Belfast Health and Social Care Trust

Can the Use of Virtual Reality Improve Outcomes Following Total Knee Arthroplasty With Spinal Anaesthesia? - A Pilot Study

Virtual reality (VR) uses computer technology to create a three-dimensional environment which the user can explore and interact with. VR can be used to distract the patient during an operation and has been used to avoid sedative premedication, increase patient satisfaction and decrease pain during nerve blocks. VR used alongside spinal anaesthetic for hip, knee and ankle operations has shown a trend of less sedation being required with no decrease in patient satisfaction.

The most common type of anaesthesia given during total knee arthroplasty (TKA) is spinal. Spinal anaesthesia is given unless there are complications or other conditions present, and general anaesthesia is given instead. General anaesthesia puts the patient to sleep during the operation, whereas spinal anaesthesia allows the patient to stay awake, but numbs the lower half of the body so no pain is felt. Sedation is usually given with spinal anaesthesia to make the patient relaxed and sleepy. Light sedation will allow the patient to be awake but relaxed, whereas deeper sedation means the patient is more likely to be asleep and less likely to recall what happened during the operation. Sedation can cause a number of side effects including nausea, vomiting, headache, drowsiness, pain, confusion, memory loss and breathing difficulties.

In this study, all patients will receive spinal anaesthesia. Group 1 will receive VR and a light level of sedation, whilst Group 2 will not receive VR but will receive a deeper level of sedation (standard of care). When using VR during TKA, a lighter level of sedation should be required. This could help to reduce side effects and aid quicker patient recovery. This pilot study aims to investigate this further.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Total joint arthroplasty (TJA) is a successful surgical intervention to reduce pain and immobility from osteoarthritis. Mortality rates following TJA are low and survival has been increasing over the last two and a half decades despite an ageing population with a higher frequency of comorbidities.

Perioperative virtual reality (VR) is a non-pharmacological technique which has been used effectively to avoid sedative pre-medication, increase patient satisfaction and alleviate procedural pain during nerve blocks. VR has been successfully utilised across different medical specialties to reduce patient anxiety associated with interventions including magnetic resonance imaging (MRI), physical therapy, dental pain, and change of burns dressings. Furthermore, a trend towards less propofol sedation with use of VR has been found in spinal anaesthetic for hip, knee and ankle operations, with no decrease in patient satisfaction. However, this small pilot study did not investigate any other outcomes other than type and amount of sedation and duration of surgery. VR use has also been shown to reduce fentanyl dose, midazolam use and pain in elective total knee arthroplasty (TKA) patients who received a pre-operative adductor canal catheter. Satisfaction of patient, surgeon and anaesthetist has also been compared when using VR and using sedation with midazolam in patients undergoing urologic surgery under spinal anaesthesia. The patient and anaesthetist satisfaction scores were significantly higher in the VR group than in the sedation group.

Sedation is associated with a number of post-operative complications including nausea, hypo/hypertension, lower respiratory tract infection, cardiac arrhythmias, peripheral nerve damage, and post-operative delirium (PD). Nausea is a common occurrence following surgery with reported incidences of 30% in all post-surgical patients and up to 80% in high-risk patients. Dose dependent hypotension is the common complication in patients who have received propofol sedation, particularly in volume depleted patients. A common cardiovascular complication during anaesthesia is arrhythmia, with 70% of patients having arrhythmia undergoing general anaesthesia for various surgical procedures. Further complications associated with propofol, although more uncommon, include hypertriglyceridemia, pancreatitis and allergic complications.

The incidence of PD is generally higher after hip fracture surgery (4-53.3%) compared to elective hip surgery (3.6-28.3%). Independent risk factors for developing inpatient delirium include dementia, age, visual impairment, functional impairment and increased comorbidities. While most studies measuring effect of propofol on sleep disturbance and PD have focussed on the critical care setting, light propofol sedation (to target a bispectral index (BIS) >80) decreased the prevalence of PD by 50% compared to deep sedation (BIS target of 50) in patients undergoing hip surgery with spinal anaesthesia. A further RCT investigated whether limiting propofol sedation with spinal anaesthesia in non-elective hip fracture repair patients reduced risk of delirium post-operatively. Patients were randomised to receive either heavier sedation (modified observer's assessment of alertness/sedation score (OAA/S) of 0-2) or lighter sedation (OAA/S of 4-5). There were no significant differences in risk of incident delirium between the heavier and lighter sedation groups. However, when stratified by Charlson comorbidity index (CCI), in low comorbid states, heavier sedation levels doubled the risk of delirium compared to lighter sedation. This randomised controlled trial (RCT) recruited hip fracture patients with a mean age of 82 years. Therefore, a similar study should be conducted in younger, less comorbid patients undergoing elective joint arthroplasty.

Sedation can also affect recovery following surgery. Being male, nausea, vomiting and pain during the ward stay have been reported to be risk factors for poor quality of recovery after sedation with midazolam for lower limb orthopaedic surgeries. Poor quality of recovery following surgery can also increase hospital stay and health care resources. No significant difference in quality of recovery has been reported between those who experienced immersive VR and those who underwent conventional care.

Propofol infusions are commonly administered alongside spinal anaesthesia for orthopaedic surgery. It is commonly given with no specific objective clinical target end point. This gives rise to the potential of administering excess propofol which may result in inadvertent deep levels of sedation. This can cause prolonged periods of inadvertent general anaesthesia depth during 'regional' cases (often without insertion of an airway device). Therefore, it is important to investigate potential ways of lowering propofol infusions during surgery, without increasing patient risk, anxiety or pain, such as through the use of VR.

Aims of Study

The aims of this pilot study are to determine:

  1. the feasibility of using VR during TKA with spinal anaesthesia.
  2. what outcomes, if any, can be influenced using VR during TKA with spinal anaesthesia.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients ≥ 18 years old who are American Society of Anaesthesiologists (ASA) grade 1 or 2 scheduled for routine primary elective knee arthroplasty.

Exclusion Criteria:

  • Patients who are ASA grade 3 or 4.
  • Patients who cannot use VR e.g. those with dementia.
  • Patients with an existing diagnosis of delirium.
  • Patients with visual impairment if degree of myopia/hyperopia exceeds the corrective power of the VR headset.
  • Patients with hearing aids.
  • Patients with previous history of motion sickness.
  • Patients with epilepsy, history of black outs or fitting.
  • Patients who will have an operation over 1 hour in duration or any patient who requires more complex surgery.
  • Patients who have requested no sedation during the operation.
  • Patients who have received premedication.
  • Patients who have a general anaesthetic.
  • Patients who do not adequately understand verbal explanations or written information given in English, or who have special communication needs.
  • Patients who are not capable of informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality
Procedure: Virtual Reality
  • VR
  • Spinal anaesthesia
  • Limited propofol aiming for OAA/S of 4-5 (light sedation)
No Intervention: Control
Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of using VR during total knee arthroplasty with spinal anaesthesia
Time Frame: Postoperative Day 1
Feasibility of using VR during total knee arthroplasty will be assessed by recruitment numbers to the study and staff and patients will be asked for their views of using the VR equipment.
Postoperative Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
4AT
Time Frame: 1 hour, 24 hours and 48 hours following skin closure.
The 4AT includes alertness, Abbreviated Mental Test 4 (AMT4), attention and acute change or fluctuating course. A score of 4 or above indicates possible delirium and/or cognitive impairment, a score of 1-3 indicates possible cognitive impairment and a score of 0 indicates that delirium or severe cognitive impairment is unlikely.
1 hour, 24 hours and 48 hours following skin closure.
Logical Memory subtest of the WMS-IV UK
Time Frame: 1 hour and 24 hours following skin closure.
The Logical Memory subtest of the WMS-IV UK will be used to assess memory recall pre-operatively, at 1 hour (+/- 30 minutes) in recovery and at 24 hours (+/- 2 hours) following skin closure. Logical Memory I assesses narrative memory under a free recall condition. Logical Memory II is a delayed condition assessing long-term narrative memory with free recall and recognition tasks.
1 hour and 24 hours following skin closure.
Total Propofol during operation
Time Frame: 1 hour following skin closure.
Total propofol administered during the operation will be recorded in mg/kg.
1 hour following skin closure.
E-entropy
Time Frame: 1 hour following skin closure.
The e-entropy system uses a disposable 4-electrode sensor on the patient's forehead to measure electrical activity in the brain before using a proprietary algorithm to process the electroencephalogram data and calculate a number between 0 (absence of brain electrical activity) and 100 (wide awake) providing an objective measure of the patient's depth of consciousness. The average e-entropy score during the operation will be recorded by calculating a mean of the trend data from the monitor log.
1 hour following skin closure.
Discharge from Recovery
Time Frame: Every 15 minutes in recovery up until 2 hours.
The time until ready for discharge from recovery will be recorded using the NEWS criteria. The time point that the following objectives are met will also be recorded; spinal regression below T4, temperature ≥36 degrees, pain score <3, nausea score between 0-1 and NEWS criteria ≤ 3.
Every 15 minutes in recovery up until 2 hours.
Mobilisation
Time Frame: 4 hours following skin closure.
Mobilisation will be assessed by a physiotherapist using the Timed Up and Go (TUG) test at 4 hours (+/- 1 hour) following skin closure. This will be recorded as the time in seconds which it takes a patient to stand up from a chair with armrests, walk 3 metres at a comfortable and safe pace, turn, walk back to the chair and sit back down again.
4 hours following skin closure.
Quality of Recovery
Time Frame: 4 hours (+/- 1 hour) and at 24 hours (+/- 2 hours) following skin closure.
Quality of recovery will be measured using the Quality of Recovery (QoR)-15 survey (Appendix 4) at 4 hours (+/- 1 hour) and at 24 hours (+/- 2 hours) following skin closure. The QoR-15 score ranges from 0 (extremely poor quality of recovery) to 150 (excellent quality of recovery).
4 hours (+/- 1 hour) and at 24 hours (+/- 2 hours) following skin closure.
IV fluids
Time Frame: Up to 1 week post operation.
Total IV fluids will be measured in ml/kg for the duration of the patient's hospital stay.
Up to 1 week post operation.
Length of stay
Time Frame: Up to 1 week post operation.
Total length of stay will be calculated using date of discharge and date of operation.
Up to 1 week post operation.
Post-operative analgesia
Time Frame: Up to 1 week post operation.
Patient notes will be assessed retrospectively for post-operative analgesia. Type and total dose of analgesia taken on each post operative 24 hour period up until discharge or up until 1 week post operation will be recorded.
Up to 1 week post operation.
Anti-emetic use
Time Frame: Up to 1 week post operation.
Patient notes will be assessed retrospectively for anti-emetic use. Type and total dose of anti-emetics taken on each post operative 24 hour period up until discharge or up until 1 week post operation will be recorded.
Up to 1 week post operation.
Any inpatient complications
Time Frame: Up to 1 week post operation.
Patient notes will be assessed retrospectively for any inpatient complications including vasovagal, fall, arrthymia, bleed, take back, and escalation of care.
Up to 1 week post operation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belfast Health and Social Care Trust

Investigators

  • Principal Investigator: David Johnston, Belfast Health and Social Care Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 28, 2024

First Submitted That Met QC Criteria

April 29, 2025

First Posted (Actual)

May 8, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 19066DJ-SW

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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