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TKR With and Without the Use of Intra-operative Sensing

Primary Purpose

Osteoarthritis

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

OrthoSensor Verasense Technology

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Total knee repalcement

Eligibility Criteria

40 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who meet the indications for use for primary TKR using IOS
Subject must be diagnosed with osteoarthritis
Subject is likely to be available for all study visits
Subject is able and willing to sign the informed consent and follow study procedures

Exclusion Criteria:

Revision total knee arthroplasty
Patient is receiving treatment for any of the following conditions:
1. Avascular Necrosis
2. Inflammatory arthritis
3. Post-traumatic arthritis
Any knee surgery other than meniscectomy (can be arthroscopic or open)
Ligament insufficiencies, prior surgeries such as anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
Ipsilateral foot/ankle and hip arthritis
Range of motion less than 90°
Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e. severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
Any subjects meeting any contraindication criteria as identified in the locally approved labeling for the device should be excluded from this study.
Patient out-of-state with medication prescription not registered in iStop database
Patients with severe contralateral osteoarthritis requiring subsequent knee replacement or with a flexion contracture greater than 10 degrees.

Sites / Locations

Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study Group

Control Group

Arm Description

The study group will have soft tissue balance performed with the use of IOS.

Control group patients will have soft tissue balance performed manually, with final soft tissue balance values measured using IOS, while the surgeon will remain blinded to those values.

Outcomes

Primary Outcome Measures

Knee Society Score

The primary outcome will be the difference in Knee Society Score (KSS) between baseline and 4 months post-operatively. The Knee Society Score is out of 100 points, with a higher score meaning a patient had a better outcome.

Secondary Outcome Measures

Intra-operative Compartment Loads

Intra-operative compartment loads (medial and lateral component loads) will be measured between the groups at 10, 45, and 90 degrees of flexion during trial reduction and after cementation, using IOS technology.

Long Leg Limb Alignment

Long leg limb alignment will be measured on post-operative standard of care (SOC) radiographs at patients' 6 week follow-ups.

Passive Range of Motion

Passive range of motion will be measured pre-operatively, 6 weeks post-operatively, and 4 months post-operatively at all scheduled SOC appointments.

Opioid Use

Use of opioids will be tracked using the Internet System for Tracking Over Prescribing (I-STOP) database and a daily pain diary maintained by patient for first 6 weeks post-operatively. The I-STOP database can be accessed by the prescribing physician to track how many opioid refills a patient has procured.

Function and Activity

Function and activity will be monitored using Fitness Trackers. The device will be given to each patient in hospital and is to be worn for 6 weeks post-operatively. It will monitor a patient's daily and weekly steps while the patient is wearing it.

Pain Level

Daily pain levels will also be measured using the fitness tracker. The tracker will ask the patient to rate their pain on a scale from 0-10, with 0 meaning they have no pain, and 10 being the worst pain imaginable.

Full Information

NCT ID

NCT04251442

First Posted

January 29, 2020

Last Updated

April 19, 2022

Sponsor

Hospital for Special Surgery, New York

Collaborators

Orthosensor, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04251442

Brief Title

TKR With and Without the Use of Intra-operative Sensing

Official Title

Randomized Controlled Trial of Patients Undergoing a Total Knee Arthroplasty With and Without the Use of Intraoperative Sensing Technology

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Per funding institution

Study Start Date

October 31, 2019 (Actual)

Primary Completion Date

October 30, 2020 (Actual)

Study Completion Date

October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital for Special Surgery, New York

Collaborators

Orthosensor, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine if there is a difference in clinical outcomes after total knee replacement (TKR) performed with traditional ligament balancing compared to use of intraoperative sensing technology (IOS) to balance ligaments. IOS is used to send real time information to a monitor within the operating room that assists your surgeon in making decisions about the balance of the ligaments in your knee and the proper insertion of implants. A total of 150 subjects will participate in this study at Hospital for Special Surgery. The hypotheses are that the use of IOS technology will be associated with: Better soft tissue balance during TKR than by manual balancing alone. Higher patient reported clinical outcome measures (PROMs) following surgery.

Detailed Description

Participation in this study will involve a knee replacement performed with IOS. Patients will be randomized into one of two groups:The study group will have soft tissue balance performed with the use of IOS. Control group patients will have soft tissue balance performed manually, with final soft tissue balance values measured using IOS, while the surgeon will remain blinded to those values. Intra-operative compartment loads will be measured in 10, 45, and 90 degrees of flexion. Additionally, long leg limb alignment, passive range of motion, use of opioids, daily activity, and PROMS will be evaluated post-operatively to determine which group has better outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

Osteoarthritis, Total knee repalcement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Group

Arm Type

Experimental

Arm Description

The study group will have soft tissue balance performed with the use of IOS.

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Control group patients will have soft tissue balance performed manually, with final soft tissue balance values measured using IOS, while the surgeon will remain blinded to those values.

Intervention Type

Device

Intervention Name(s)

OrthoSensor Verasense Technology

Intervention Description

IOS is used to send real time information to a monitor within the operating room that assists your surgeon in making decisions about the balance of the ligaments in your knee and the proper insertion of implants.

Primary Outcome Measure Information:

Title

Knee Society Score

Description

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Intra-operative Compartment Loads

Description

Time Frame

Intra-operative

Title

Long Leg Limb Alignment

Description

Long leg limb alignment will be measured on post-operative standard of care (SOC) radiographs at patients' 6 week follow-ups.

Time Frame

6 weeks

Title

Passive Range of Motion

Description

Passive range of motion will be measured pre-operatively, 6 weeks post-operatively, and 4 months post-operatively at all scheduled SOC appointments.

Time Frame

4 months

Title

Opioid Use

Description

Time Frame

6 weeks

Title

Function and Activity

Description

Time Frame

6 weeks

Title

Pain Level

Description

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who meet the indications for use for primary TKR using IOS Subject must be diagnosed with osteoarthritis Subject is likely to be available for all study visits Subject is able and willing to sign the informed consent and follow study procedures Exclusion Criteria: Revision total knee arthroplasty Patient is receiving treatment for any of the following conditions: Avascular Necrosis Inflammatory arthritis Post-traumatic arthritis Any knee surgery other than meniscectomy (can be arthroscopic or open) Ligament insufficiencies, prior surgeries such as anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures Ipsilateral foot/ankle and hip arthritis Range of motion less than 90° Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e. severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease) Any subjects meeting any contraindication criteria as identified in the locally approved labeling for the device should be excluded from this study. Patient out-of-state with medication prescription not registered in iStop database Patients with severe contralateral osteoarthritis requiring subsequent knee replacement or with a flexion contracture greater than 10 degrees.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alejandro Gonzalez Della Valle, MD

Organizational Affiliation

Hospital for Special Surgery, New York

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kate Shanaghan

Organizational Affiliation

Hospital for Special Surgery, New York

Official's Role

Study Director

Facility Information:

Facility Name

Hospital for Special Surgery

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30053812

Citation

Cho KJ, Seon JK, Jang WY, Park CG, Song EK. Objective quantification of ligament balancing using VERASENSE in measured resection and modified gap balance total knee arthroplasty. BMC Musculoskelet Disord. 2018 Jul 27;19(1):266. doi: 10.1186/s12891-018-2190-8.

Results Reference

result

PubMed Identifier

27436499

Citation

Nodzo SR, Franceschini V, Gonzalez Della Valle A. Intraoperative Load-Sensing Variability During Cemented, Posterior-Stabilized Total Knee Arthroplasty. J Arthroplasty. 2017 Jan;32(1):66-70. doi: 10.1016/j.arth.2016.06.029. Epub 2016 Jun 22.

Results Reference

result

Learn more about this trial

TKR With and Without the Use of Intra-operative Sensing

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