Orthosensor vs Conventional Total Knee Arthroplasty

September 30, 2021 updated by: Jeffrey Geller, Columbia University

Outcomes in Free-hand Versus Sensor-guided Balancing in Total Knee Arthroplasty: a Randomized Controlled Trial

In a randomized-controlled fashion, this investigation will evaluate the use of the Verasense technology to achieve optimal TKA balance. Patients will be randomized to either: 1) undergo manual soft tissue balancing or 2) soft tissue balancing with the Verasense. The primary outcomes of interest will include patient-reported outcomes as well knee range of motion at 3 months, 6 months, 1 year, and 2 years. Secondary outcomes of interest will include pain level as assessed by the visual analogue scale (VAS) in the acute post-operative and follow up periods, ambulation distance during inpatient physical therapy postoperatively, surgical time, tourniquet time, amount of opioid consumption, length of hospital stay, incidence of arthrofibrosis and subsequent manipulation under anesthesia. The investigators hypothesize that the use of the Verasense technology will lead to improved soft tissue balancing in TKA and ultimately result in favorable patient-reported outcomes and postoperative knee range of motion.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Total knee arthroplasty (TKA) is one of the most successful surgical procedures performed worldwide, and if conducted properly, has proven to improve pain, knee range of motion, and ultimately quality of life. Approximately 700,000 TKAs are performed annually in the United States, and this number is projected to increase to 3.48 million annually by 2030. Unfortunately, roughly 20% of patients who undergo TKA are dissatisfied with their outcome and this number has remained stagnant for the past decade.Patient satisfaction after TKA is predominantly driven by postoperative pain and function.

Outcomes in TKA are influenced by multiple factors, stemming from patient-specific factors and surgically modifiable factors. Patient specific factors include body mass index (BMI), preoperative range of motion (ROM), psychological status, and other comorbidities; examples of surgically modifiable factors include the type of prosthesis utilized, posterior condylar offset, posterior tibial slope, and soft tissue balancing. Knee arthritis is a disease not only of the condylar surfaces, but of the soft tissues as well. As such, the success of a TKA depends on the ultimate restoration of the integrity of the knee articular surfaces,necessitating two critical elements, beginning with precise osteotomies and ending with soft tissue balancing to realign the lower extremity to a neutral mechanical axis.

In the last three decades, this first element has been addressed by major technological advances to perform precise and reproducible osteotomies, most recently with the development of computer-assisted navigation and validation techniques and modalities that allow osteotomies based on anatomical jigs created by CT imaging of the patient's knee.

Despite these advances, little advancement has been appreciated by the second element-soft tissue balancing.While precise osteotomies are critical to the success of a TKA, they do not address ligamentous stability and balance, which if absent, leads to knee instability, stiffness, accelerated prosthetic wear, aseptic loosening, and premature implant failure. Soft tissue imbalance accounts for 35% of early TKA revisions in the United States. Soft tissue balancing in TKA has traditionally been more of an art than a science, relying exclusively on the surgeon's subjective assessment based on nebulous tactile feedback after completion of the osteotomies. The diseased soft tissues (i.e. ligaments) may be lengthened, tightened, or released to achieve balance, range of motion, and functional stability. However, these methods are numerous, variable, and above all, highly subjective. The individual experience of the surgeon, including fellowship training and procedural volume play a role in their ability to balance a knee properly.

Typically, it is only after many years of experience does the surgeon develop the ability to accurately assess stability in varus, valgus, anterior and posterior planes.Objective balancing of soft tissues in TKA may contribute to a decrease in pain, improve function, patient satisfaction, and ultimately decrease the rate of revision. The need for the transformation of TKA soft tissue balancing from an art to a science has been realized by a technology that allows surgeons to objectively quantify ligament balance by offering real-time, evidence-based data during TKA. The Verasense (Orthosensor Inc., Dania, FL) is a disposable wireless device embedded with force sensors and inserted into the tibial component during the trialing phase of surgery after gross balancing, allowing real-time loading values in the medial and lateral compartments of the knee and fine-tuning of the end result by further soft tissue releases to improve balance and stability.

Balance in TKA is defined as stability in the sagittal plane and less than 15 pounds difference in the medial and lateral compartments of the knee. In a multicenter study, intraoperative sensors were utilized to define balance and to correlate it with improved clinical outcomes. TKAs that had undergone said balancing were compared to unbalanced TKAs, with results showing improved Knee Society Score (KSS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) between balanced (172, 14.5 points) and unbalanced (145.3, 23.8 points), respectively. The authors concluded that a well-balanced TKA was the most significant contributing factor to improved postoperative outcomes.

Similarly, Chow et al. investigated six-month patient-reported outcomes in a small retrospective cohort study with short-term follow up of six months comparing sensor-assisted to non-sensor-assisted TKA balancing. They reported that the KSS, Oxford Knee Score, and knee range of motion was significantly higher in the sensor-assisted cohort and that the rate of arthrofibrosis was lower in the sensor-assisted group, however, not statistically significant.

Further, Geller et al. retrospectively compared the incidence of arthrofibrosis before and after the implementation of the Verasense technology to assist with ligament balancing and reported a 5% rate of arthrofibrosis prior to implementation versus 1.6% after. In this same report, median length of surgery was 83 minutes before implementation compared to 115 minutes after. The authors reported that while the implantation of the sensor increased operative time, this additional time does not have a clinical impact and that the benefits outweigh this potential increase in operative time. Multiple reports in the literature have suggested that a well-balanced TKA, which leads to increased activity levels may be part of a cascade effect, which ultimately results in higher patient-reported outcome scores.

Unfortunately, soft tissue balancing is one of the only remaining aspects of TKA that has not benefited from a consensus based on quantitative measures and objective data. As the economic environment changes in medicine, coupled with a five-fold increase in TKAs performed and the subsequent need for less experienced surgeons to perform TKAs, it is imperative that the traditional subjectivity once relied upon be replaced by more empirical and clinical data to construct a scientific consensus of what balance is. In so doing, clinical outcomes may be improved, with a resultant decrease in the rate of early revisions, and ultimately significant savings in healthcare expenditures.While the literature has demonstrated a clear advantage by technology like the Verasense, previous studies have predominantly been underpowered, with short-term follow up, and unstandardized TKAs, including surgical approach, prosthetic designs, manufacturer, and above all, not randomized and controlled.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronxville, New York, United States, 10708
        • NewYork-Presbyterian Lawrence Hospital
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary total knee replacement

Exclusion Criteria:

  • Revision knee surgery
  • Prior knee surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Non-Sensor Group
Patients will undergo standard total knee replacement surgery without Verasense assisted balancing technology.
Experimental: Sensor Group
Patients will undergo total knee replacement surgery with Verasense assisted balancing technology.
Device: Verasense
Ligamentous balancing device
Other Names:
  • Orthosensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Veterans RAND12 Item Health Survey
Time Frame: 1 year
The investigators will ask participants to answer survey questions about knee functionality on a scale of 0-100, 0 being the least functionality and 100 being the most.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale pain level
Time Frame: 1 week
Pain levels on a scale from 1-10 (1 being the least amount of pain possible and 10 being the most amount of pain possible).
1 week
Ambulation (distance)
Time Frame: 1 week
ambulation distance during inpatient physical therapy postoperatively
1 week
Range of motion
Time Frame: 1 year
physical examination of knee
1 year
KOOS Knee Survey
Time Frame: 1 year
The investigators will ask participants to answer survey questions about knee functionality on a scale of 0-100, 0 being the least functionality and 100 being the most.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Jeffrey Geller, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2017

Primary Completion (Anticipated)

September 20, 2022

Study Completion (Anticipated)

December 20, 2022

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

October 1, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAR6137

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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