ARVIS TKA vs Conventional TKA
ConditionOsteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFoundation for Orthopaedic Research and Education
About this trial
This study is a pilot analysis of a novel augmented reality guidance platform, the augmented reality visualization and information system (ARVIS, Insight Medical), with aims to demonstrate accuracy of bone resection and implant alignment during kinematic alignment total knee arthroplasty.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years old
Scheduled for primary conventional TKA with kinematic alignment
Primary Diagnosis of Osteoarthritis (Killgren Lawrence Grade > III) on affected side
Able to provide informed consent
Disqualifiers
Patients with a previous operation of the same knee, including ACL reconstruction, fracture fixation, previous arthroplasty.
Patients that had a conversion to a different procedure intraoperatively or shortly after the TKA.
Diagnosed with greater than Killgren Lawrence Grade II OA on the contralateral knee
Patients that did not complete the TKA.
Trial design
Design model
Parallel
Treatments tested in this trial
Evaluation of Augmented Reality technology in TKA compared to standard TKA
Other interventionEvaluation of effectiveness of AR system used to perform bone cuts when compared to traditional jigs in primary TKA
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: ARVIS armExperimental treatment 1 intervention
Group B: conventional TKAPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Radiographic Measurements bilateral knees
Weight bearing anterposterior (AP), lateral and sunrise views of both knees to measure tibial slope, hip-knee alignment, medial proximal tibial angle, mechanical lateral distal femoral angle, joint line convergence angle, anatomic- mechanical angle.
Time frame
From enrollment until 1 year follow-up visit.Secondary outcomes
1
PROMIS-10 Survey
Patient Reported Outcome Measure Information System with 10 questions about subjects pain and function.
Time frame
frome enrollment until 12 month final study visit2
Knee Society Score (KSS)
A simple and objective scoring system to rate the knee and patient's functional abilities before and after total knee arthroplasty.
Time frame
From enrollment until final visit at 12 months after surgery3
Knee Injury and Osteoarthritis outcome Score (KOOS)
KOOS is a 42-item questionnaire that assesses the patient's opinion about the health, symptoms, and functionality of their knee.
Time frame
from enrollment until completion of study at 12 months post surgery4
Numeric Pain Rating Score (NPRS)
1-10 numeric scale that asks patients to rate their pain in the last 24 hours.
Time frame
From enrollment until final study visit at 12 months post surgeryOther outcomes
1
Virtual Reality Sickness Questionnaire (VSRQ)
A motion sickness measurement index specialized in VR environments. 16 questions broken down into three categories (nausea, oculomotor, and disorientation) to assess the severity of each potential cybersickness symptom.
Time frame
After the surgical procedure - one time onlySponsors and contacts
Click on the lead sponsor to view all of their trials.
Foundation for Orthopaedic Research and Education
Lead sponsor
DonJoy Orthopedics
Collaborator
Source ClinicalTrials.gov