TKR With and Without the Use of Intra-operative Sensing

NCT04251442 | Withdrawn FDA Device

• 1 other identifier: 2019-0144
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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:

1. 1.Better soft tissue balance during TKR than by manual balancing alone.
2. 2.Higher patient reported clinical outcome measures (PROMs) following surgery.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Total knee repalcement

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Secondary Outcomes (6)

• Intra-operative Compartment Loads

  Intra-operative

• Long Leg Limb Alignment

  6 weeks

• Passive Range of Motion

  4 months

• Opioid Use

  6 weeks

• Function and Activity

  6 weeks

Study Arms (2)

Study Group

EXPERIMENTAL

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

Device: OrthoSensor Verasense Technology

Control Group

NO INTERVENTION

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.

Interventions

OrthoSensor Verasense Technology DEVICE

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.

Study Group

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Orthosensor, Inc.: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (2)

• 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.

  PMID: 30053812 RESULT

• 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.

  PMID: 27436499 RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Alejandro Gonzalez Della Valle, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

• Kate Shanaghan

  Hospital for Special Surgery, New York

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 5, 2020
• Study Start: October 31, 2019
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)