Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing

PILOT STUDY: Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing: A Randomized, Double-Blind, Controlled Trial

The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and correlate Intra-operative subjective feel with OrthoSensor Outputs

Secondary objectives are to quantify and observe:

• Pain medication use
• Swelling
• Muscle strength and girth
• Gait efficiency
• Patient satisfaction
• Activity levels, functional return (i.e., back to work, resume normal activities)
• Patient perception of a balanced knee

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: Control - Without the use of Verasense; Device: Sensor-assisted TKR (Verasense)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21215-5271
      • Sinai Hospital of Baltimore - Rubin Institute of Advanced Orthopedics Center for Joint Preservation and Reconstruction

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject must be a candidate for a primary PCL retaining total knee arthroplasty
• Subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis, post-traumatic arthritis
• Subject is between the age of 45 - 80 years
• 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:

• Prior total knee arthroplasty, ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
• Range of Motion less than 90 degrees, flexion contracture of more than 20 degrees

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Control - Without the use of Verasense; Total Knee Replacement without the use of intraoperative sensors	Procedure: Control - Without the use of Verasense; Patients in this cohort will undergo manual total knee replacement without the use of Verasense
ACTIVE_COMPARATOR: Sensor-assisted TKR (Verasense); Total Knee Replacement with the use of intraoperative sensors	Device: Sensor-assisted TKR (Verasense); Verasense is a single use, disposable device embedded with microelectronics into a standard tibial trial to provide dynamic, intraoperative feedback regarding limb alignment, tibiofemoral position and quantitative pressure at peak contact points in the medial and lateral compartments during total knee replacement surgery. Utilizing sensor-derived data, the surgeon can now evaluate intercompartmental loading throughout the range of motion, and correct for soft-tissue abnormalities while receiving real-time feedback regarding joint balance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rehabilitation Potential	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Pain and Functional Scoring (KSS)	The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.	6 month
Forgotten Joint Score (FJS)	The FJS is based on the patients' ability to forget about a joint as a result of the treatment. The FJS assessment is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities.	6 month
3D Gait Analysis velocity	3D gait analysis relates to the range of motion of a joint and the movement velocity. The mean gait speed analysis is considered higher than 1 m/s.	6 Month

Collaborators and Investigators

• Sponsor: Orthosensor, Inc.
• Investigators: Principal Investigator: Ron Delanois, MD, Sinai Hospital of Baltimore

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ACTUAL): October 12, 2022
• Study Completion (ACTUAL): October 12, 2022

Study Registration Dates

• First Submitted: October 31, 2014
• First Submitted That Met QC Criteria: November 8, 2014
• First Posted (ESTIMATE): November 13, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Intraoperative Sensors; Clinical Outcomes; Primary PCL-retaining Total Knee Arthroplasty; Ligament Balancing
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 101 (Other Identifier: Hamilton Integrated Research Ethics Board)

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