Knee InjuriesNCT03053453

Evaluation of Patient Reported Outcomes (PRO) After Total Knee Arthroplasty (TKA) Under Spinal Anesthesia

A study testing Spinal Surgery and Verasense Knee System device in people with Knee Injuries, run by NYU Langone Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study will be to evaluate and compare patients undergoing total knee arthroplasty (TKA) with sensor guidance versus that of a standard technique. Each patient will be assessed for the difference between passive, soft tissue controlled, pressure balance and muscle activated pressure balance. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Knee Injuries
What is being tested?: Spinal Surgery and Verasense Knee System device
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteUnited States
Study dates: 6 Dec 2016to 13 Jul 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Failure to complete pre-operative surveys.
Revision Total Knee Arthroplasty
Prior ipsilateral knee surgery such as ligament reconstruction or osteotomy
Contralateral Total Knee Arthroplasty
Prior tibial plateau fracture
Ligamentous Insufficiency
History of fibromyalgia, chronic fatigue syndrome

Trial locations and contacts

1 site in 1 country.

United States1 site

New York University School of Medicine
New York, New York, 10016

Other trials in United States

About this study

Official title: Evaluation of the Patient Reported Outcomes After Sensor-guided Total Knee Arthroplasty Under Spinal Anesthesia With Limited Motor-block.

Conditions: Knee Injuries
Being tested: Spinal Surgery, Verasense Knee System device
Keywords: Total Knee Replacement Arthroplasty
Medical subject headings: Knee Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spinal SurgeryProcedure or surgery
TKA under standard of care spinal surgery.
Verasense Knee System deviceDevice
Also called OrthoSensor
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 groups in NCT03053453
Study group	Role	What they receive
Standard of Care Spinal Surgery	Active comparator	Patients will be given spinal anesthesia with 2.6 mL of 0.5% isobaric bupivacaine. Receives: Procedure: Spinal Surgery
Sensor Guided Spinal Surgery	Experimental	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. Receives: Device: Verasense Knee System device

What is being measured

The primary outcome is the main question the study is designed to answer.

Knee Society Score (KSS)
The Knee Society Score (KSS) comprises two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.
Measured: Month 12 Post-Surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS)
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, function in daily living (ADLs), sports/recreation, and quality of life. The maximum score a patient can achieve is 100, indicating no knee problems. The minimum score is zero, indicating severe knee problems.
Measured: Month 12 Post-Surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 201613 Jul 2022

First posted15 Feb 2017
Study start6 Dec 2016
Primary completion13 Jul 2022
Study completion13 Jul 2022

Why it stopped: Departure of study surgeon investigator.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Knee InjuriesStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03053453
Sponsor's protocol ID: 16-00129
Status last verified: Oct 2023
First submitted: 30 Jan 2017
Last updated: 14 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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All Knee Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Patient Reported Outcomes After Sensor-guided Total Knee Arthroplasty Under Spinal Anesthesia With Limited Motor-block.
ClinicalTrials.gov ID: NCT03053453
Acronym / sponsor ID: 16-00129
Conditions: Knee Injuries
Keywords: Total Knee Replacement Arthroplasty
Study type: Interventional
Recruitment status: TerminatedReason stopped: Departure of study surgeon investigator.
Enrolment: 52 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Study start: 6 Dec 2016 (actual)
Primary completion: 13 Jul 2022 (actual)
Study completion: 13 Jul 2022 (actual)
First posted: 15 Feb 2017 (actual)
Results: Posted 14 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Standard of Care Spinal Surgery	Active comparator	Procedure: Spinal SurgeryPatients will be given spinal anesthesia with 2.6 mL of 0.5% isobaric bupivacaine.
Sensor Guided Spinal Surgery	Experimental	Device: Verasense Knee System deviceThe 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.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

Failure to complete pre-operative surveys.
Revision Total Knee Arthroplasty
Prior ipsilateral knee surgery such as ligament reconstruction or osteotomy
Contralateral Total Knee Arthroplasty
Prior tibial plateau fracture

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Spinal SurgeryTKA under standard of care spinal surgery.	Procedure or surgery	Standard of Care Spinal Surgery
Verasense Knee System deviceAlso: OrthoSensorSensor 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.	Device	Sensor Guided Spinal Surgery

Primary outcome

Knee Society Score (KSS)
Time frame: Month 12 Post-Surgery
The Knee Society Score (KSS) comprises two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Month 12 Post-Surgery
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, function in daily living (ADLs), sports/recreation, and quality of life. The maximum score a patient can achieve is 100, indicating no knee problems. The minimum score is zero, indicating severe knee problems.

Results and safety

Results posted to the registry on 14 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care Spinal Surgery	26	26
Sensor Guided Spinal Surgery	26	26

Primary outcome: Knee Society Score (KSS)

Time frame: Month 12 Post-Surgery

Population analysed: This study was interrupted as the surgeon investigator decided to retire from clinical practice. Following the surgeon investigator's assessment, no intervention was performed based on the intra-operative results of the pressure load measurement. For that reason, the PI deemed the study team should not compare the surgical results using the KSS. Therefore, this measure was not assessed among study participants; no data are available for this outcome measure as it was not assessed.

Primary outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)

Time frame: Month 12 Post-Surgery

Population analysed: This study was interrupted as the surgeon investigator decided to retire from clinical practice. Following the surgeon investigator's assessment, no intervention was performed based on the intra-operative results of the pressure load measurement. For that reason, the PI deemed the study team should not compare the surgical results using the KOOS. Therefore, this measure was not assessed among study participants; no data are available for this outcome measure as it was not assessed.

Adverse events

Time frame: 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care Spinal Surgery	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Sensor Guided Spinal Surgery	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Knee Injuries

Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function
Meniscal Tears
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Arthur Hertling, MD principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Spinal Surgery and Verasense Knee System device in people with Knee Injuries, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee Society Score (KSS) (time frame: Month 12 Post-Surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03053453.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.