Evaluation of the Patient Reported Outcomes After Sensor-guided Total Knee Arthroplasty Under Spinal Anesthesia With Limited Motor-block.
Phase: NA
Conditions: Knee Injuries
Sponsor: NYU Langone Health

 
 
Official Title: 
Evaluation of the Patient Reported Outcomes After Sensor-guided Total 
Knee Arthroplasty Under Spinal Anesthesia With Limited Motor-block.   
NCT Number: 
NCT03053453 
Study Number: 
16-00129 
Document Type:  
Study Protocol  
Date of the 
Document: 
• 
February 2, 2021 
  

 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center.  Do not disclose or use except as 
authorized in writing by the study sponsor 
 
 
 
 
 
 
 
 
 
Evaluation of the patient reported outcomes after 
sensor-guided total knee arthroplasty under 
spinal anesthesia with limited motor-block. 
 
 
 
 
Regulatory Sponsor: 
Department of Orthopaedic Surgery 
301 E. 17th Street 
New York, NY 10003 
Principal Investigator: 
Co-investigators: 
Arthur C. Hertling, MD, FASA 
Patrick Meere, MD 
Kristopher Collins, MD 
Germaine Cuff, BSN, PhD 
 
 
 
Protocol Number: 
 S16-00129 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Initial version:  November 8, 2016 
Clinical Research Protocol 

1 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center.  Do not disclose or use except as 
authorized in writing by the study sponsor 
 
I. PURPOSE OF THE STUDY AND BACKGROUND 
 
Purpose 
 
The purpose of this study will be to evaluate and compare patients undergoing TKA with sensor guidance 
versus that of a standard technique. Secondly, each patient will be assessed for the difference between 
passive, soft tissue controlled, pressure balance and muscle activated pressure balance. 
We hypothesize that patients undergoing TKA with sensor guidance will have consistently higher 
satisfaction rates compared with standard technique and that muscle activated pressure balance will 
demonstrate a similar ratio of the medial to lateral compartment as that of the passive pressure balance. 
 
 
Rationale 
 
 
Total Knee Arthroplasty (TKA) is a successful and cost-effective method to relieve pain and improve 
function and quality of life in patients with advanced knee arthritis. Despite these reported benefits, 75-89% 
of patients are not satisfied with the outcome of their TKA. Thus, it behooves the surgeon to further 
investigate the reasons for this dissatisfaction. Besides unhappy patients and increased TKA revision rates, 
unsatisfactory outcomes lead to a high socio-economic burden. 
 
The reliably of a successful total knee replacement is dependent on appropriate alignment of components, 
rotation congruency between components and ligamentous balance of the knee joint. The use of robotic 
systems and CT imaging has allowed for the surgeon to ensure correct alignment and anatomic rotation of 
the components but obtaining soft tissue balance remains elusive. Balance of a TKR is determined by 
numerous methods that are variable and highly subjective. This is dependent not only on a surgeons’ 
experience, training and procedural volume but the patients BMI, gender and relative ligament laxity. 
Instability is cited in up to 22% of reported reasons for revision. In patients with instability the increased 
laxity in the soft tissue can cause pain, effusions, and inability to traverse curbs and inclined planes.  
 
Reduction of these complications is essential to minimize the percentage of revision surgeries performed. 
Real-time data, presented intraoperatively can assist the surgeon in achieving a well-aligned and well-
balanced knee. The Verasense Knee System device (OrthoSensor inc., Dania Beach, Florida) is a sterile 
sensor system that replaces the tibial insert trials used during surgery. The sensor contains a 
microprocessor and integrated nanosensor system, which wirelessly transmits real-time data to a portable 
graphic display unit used for read-out of the data. The sensor measures and localizes peak load at the 
medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through 
the full range of movement (ROM) using the sensor system. 
 
 
Study Design 
This is a randomized prospective study looking at the impact sensor guidance has on the outcome of 
patients and comparing to that of patients with a standard technique. The study is also designed to evaluate 
the difference between passive, soft tissue controlled, pressure balance and muscle activated pressure 
balance. Prior to the randomized study, there will be an observational pilot of 25 patients. These patients 
will not be randomized and will receive standard of care anesthesia.  The reason for the 25 pilot patients is 
to perfect the sensor guidance so all subsequent study patients will have a streamlined, consistent 
measurement. 
 
Primary Objective 
The primary study objective is to evaluate patient outcomes following surgery with the use of the 
new Knee Society Score and the Knee Injury and Osteoarthritis Outcome Score (KOOS).  
 
Secondary Objective 

2 
 
 
CONFIDENTIAL 
Do not disclose or use except as authorized in writing by the study sponsor 
 
The secondary objective is to evaluate and compare the difference between passive, soft tissue controlled, 
pressure balance and muscle activated pressure balance at the time of surgery.  
 
Further patient data that will be collected and evaluated will be: kinematic data including varus/valgus and 
anteroposterior stability, the presence of a flexion contracture or extension lag, anatomical alignment and 
ROM 
 
II. CHARACTERISTICS OF THE RESEARCH POPULATION 
 
Number of Subjects 
The total number of subjects will be approximately 125.  We would like to observe 25 patients as part of a 
pilot, preliminary study. These patients will not be randomized and will receive standard of care anesthesia.  
The reason for the 25 pilot patients is to perfect the sensor guidance so all subsequent study patients will 
have a streamlined, consistent measurement.  Approximately 100 subjects will be enrolled into the 
randomized study. 
 
Gender of Subjects  
Men and women will be included in this study. 
 
Age of Subjects 
Subjects should be at least 50 years of age  
 
Racial and Ethnic Origin 
There are no enrollment restrictions based on race or ethnic origin. 
 
Inclusion Criteria 
Patients will be screened for eligibility based on whether they have chronic knee pain as a result of an 
arthritis-related condition. 
• 
Patient with chronic knee pain who is indicated for total hip or knee replacement surgery 
• 
Patient is at least 50 years of age 
• 
Patient is willing to participate in pre- and postoperative surveys 
 
Exclusion Criteria 
• 
Failure to complete pre-operative surveys. 
• 
Revision Total Knee Arthroplasty 
• 
Prior ipsilateral knee surgery such as ligament reconstruction or osteotomy 
• 
Simultaneous Contralateral Total Knee Arthroplasty 
• 
Prior tibial plateau fracture 
• 
Ligamentous Insufficiency 
• 
History of fibromyalgia, chronic fatigue syndrome 
 
 
Vulnerable Subjects 
Although this population may include the elderly, which is a vulnerable population, we are not specifically 
targeting vulnerable subjects. 
 
III. METHODS AND PROCEDURES 
 
Methods and Procedures  
After patients are enrolled in the study by meeting the inclusion criteria, subjects will participate in the study 
until 12 months after their knee replacement surgery. We estimate it will take 18 months to enroll all study 
subjects.  
 

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CONFIDENTIAL 
Do not disclose or use except as authorized in writing by the study sponsor 
 
Visit 1: Immediate visit prior to surgery: Obtain consent and gather kinematic data including varus/valgus 
and anteroposterior stability, the presence of a flexion contracture or extension lag, anatomical alignment, 
ROM, and patient reported outcome measures, by use of the new Knee Society Score and the Knee Injury 
and Osteoarthritis Outcome Score KOOS 
 
Visit 2: The day of surgery. Patients will undergo TKA performed under one of two spinal anesthesia 
protocols. Patients will be randomized into one of the two groups at their first visit. 
• 
Protocol 1 – the current standard of care. Patients will be given spinal anesthesia with 2.6 mL of 
0.5% isobaric bupivacaine. 
• 
Protocol 2 – spinal anesthesia using a solution of 1ml of 0.5% isobaric bupivacaine in combination 
with 1.5 cc of sterile saline solution containing 7.5 micrograms of sufentanil 0.005mg/ml. Using this 
technique motor function of the operated leg is not inhibited during surgery. This is a sensation-
only block with no added medical or pain risk to the patient. While it is true that many studies using 
intrathecal sufentanil use 5 mcg rather than 7.5 mcg [16], in this case, because of the reduced dose 
of local anesthetic, we elected to increase the dose of sufentanil to ensure that the patient would 
not experience pain. In our clinical experience, as well as in the published literature [17-27], 
especially in obstetrics, where preservation of motor function is especially important, a dose of 7.5 
or 10 mcg does not seem to cause more adverse effects than 5 mcg. 
During the surgery, each patient will be momentarily awakened and asked to move their leg in order to 
measure pressure balance and the results recorded. This poses no additional risk to the patient, who 
will have no conscious memory of the experience. Pressure balance and soft-tissue balancing of the 
knee is typically done as a standard of care for all patients, yet we hypothesize that utilizing the wakeup 
test in this study will improve the accuracy of soft-tissue balancing techniques. Following implantation 
of the final components the knee pressure will again be tested in both the passive and active state. 
Patients in the pilot portion (25 subjects) will only receive PROTOCOL 1.  They will receive all other 
aspects of the study, 
 
Visit 3: 3 months post-surgery: Re-administer Knee Society Score/KOOS and gather physical data 
 
Visit 4: 6 months post-surgery: Re-administer Knee Society Score/KOOS and gather physical data 
 
Visit 5: 12 months post-surgery: Re-administer Knee Society Score/KOOS and gather physical data 
 
 
Data Storage and Confidentiality 
All research data will be recorded into a password-protected database and stored in the offices of the 
investigators on a password-protected computer.  After initial data collection, all private health information 
will be removed, and patients will be tracked with an anonymous study number.  The collected data will be 
permanently deleted immediately after the completed study is accepted in full for publication. 
 
Participant medical information will be stored electronically within a password protected database available 
only to the principal investigator, co-investigators, and research staff as necessary for data analysis.  The 
names and medical record numbers of the study participants will be deleted from their stored medical 
information and replaced with a linkage code.  Access to participant medical information contained within 
the registry will be restricted. 
 
IV. RISK/BENEFIT ASSESSMENT 
 
This study involves only minimal risk to the patient. There is a risk of breach of confidentiality. 
 
Protection against Risks  
All patients will be de-identified and given a code. Information linking the patient codes to the participants’ 
names and medical record numbers will be stored in a secure location separate from the medical 
information.  Access to the information linking the linkage codes with participant identifiers shall be 
restricted. 

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CONFIDENTIAL 
Do not disclose or use except as authorized in writing by the study sponsor 
 
 
Potential Benefits to the Subjects  
Benefits of the study include the possibility of improved satisfaction and knee stability. It is the hope of the 
research team that results of this study will benefit future patients and their physicians by allowing for 
improved outcomes with better knee stability during total knee arthroplasty.  
 
V. INVESTIGATOR’S QUALIFICATIONS AND EXPERIENCE 
 
A copy of the senior investigator’s CVs is available. All investigators and research personnel have 
completed training in the protection of human subjects. 
 
VI. SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT/ASSENT 
 
Method of Subject Identification and Recruitment 
Upon IRB approval, the research assistants will begin screening patients to be seen in health clinics in the 
upcoming days.  Appropriate patients, who meet all of the inclusion criteria and none of the exclusion criteria 
will be identified by the treating surgeon, and will be asked about interest in participating in the research 
study. If the patient has an interest, he/she will then be approached by a research assistant after leaving 
the surgeon’s office. If the patient consents, a more complete search of each patient’s medical record will 
then be conducted.  They will note each patient’s gender, age and pertinent medical history. Should a 
patient meet any exclusion criteria, it will be noted in the screening log and that patient will not be 
approached for inclusion in the study.  
 
Process of Consent 
Written consent will be obtained from subjects who are eligible candidates for the total knee replacement 
(as determined by their physician). The consent process will take place during an office visit at which time 
the investigator has determined subject’s voluntary participation has been upheld.  Subjects will be informed 
about the study and the intended purpose. They will be given the opportunity to ask questions and receive 
thorough explanations. They will be made aware of the possible risks and anticipated benefits. They will 
also be informed of alternative procedures. Subjects will then be given another opportunity to ask questions 
and agree or disagree to consent.   
 
Subject Capacity 
All subjects enrolled in this study will have capacity to provide informed consent. 
 
Debriefing Procedures 
Information will not be withheld from any participant, as they will be self-administering all survey items. 
 
Consent Forms 
Informed consent will be obtained from all subjects and documented with a signed, written consent form 
using the NYU IRB’s English standard consent form. 
 
Documentation of Consent 
Documentation of consent will be maintained in the study’s regulatory binder. 
 
Costs to the Subject 
Subjects will not incur any additional financial costs as a participant in this study. 
 
Payment for Participation  
No payments/reimbursements will be provided to subjects for their participation in this study. 
 
 
VII. References 
 

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CONFIDENTIAL 
Do not disclose or use except as authorized in writing by the study sponsor 
 
1. 
Reichmann WM, Wright EA, Holt HL, Solomon DH. Cost-effectiveness of Total Knee 
Arthroplasty in the United States. 2012;169(12):1113–21.  
2. 
Bourne RB, Chesworth BM, Davis  a M, Mahomed NN, Charron KD. Patient satisfaction after 
total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res [Internet]. 
2010 Jan [cited 2014 Oct 16];468(1):57–63.  
3. 
Vissers MM, de Groot IB, Reijman M, Bussmann JB, Stam HJ, Verhaar JA. Functional capacity 
and actual daily activity do not contribute to patient satisfaction after total knee arthroplasty. 
BMC Musculoskelet Disord. 2010;11:121.  
4. 
Noble PC, Conditt M a, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect 
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