Making Sense Out of Total Knee Sensor Assisted Technology: A Randomized Control Trial

The purpose of this study is to compare the patient reported outcome measures of total knee replacement patients who received intra operative sensor guided technique for soft tissue balancing to a group of patients who receive surgeon guided soft tissue balancing.

Study Overview

• Status: Unknown
• Conditions: Arthroplasty, Replacement, Knee
• Intervention / Treatment: Device: Verasense

Detailed Description

This study will compare a group of total knee arthroplasty patients who receive sensor guidance technology for soft tissue balancing intra operatively to a group of patients who receive surgeon guided soft tissue balancing. Patients will be randomized to either the experimental group with the sensor guided technology or the control group which is the surgeon guided technique and current standard of care. All patients will have the sensor placed intra operatively so that measurements can be captured and recorded however, the measurements for the patients who are not in the sensor guided group will not be revealed to the surgeon. The information will be gathered for post enrollment data analysis only. The patients measurements in the sensor guided group will be revealed to the surgeon and the surgeon will use this information in order to help guide soft tissue balancing for optimal alignment intra operatively. Patients will be followed for 1 year post operatively. Patient reported outcomes measures such as KSS, KOOS, PROMIS PF CAT, EQ-5D and UCLA activity will be collected preoperatively and at 3 months, 6 months, and 12 months. Post-operative Likert scale patient satisfaction scores will also be collected. All outcomes will be scored and compared to determine significance.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samarian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing primary unilateral total knee arthroplasty for osteoarthritis, avascular necrosis, inflammatory arthropathy, or post traumatic arthritis.
• Patients able to understand study intent, and agree to study participation.
• Patients receiving Smith and Nephew Journey II total knee implant system.

Exclusion Criteria:

• Patients with previous ipsilateral knee ligament surgery.
• Patients with orthopaedic and medical co-morbidities that would thwart postoperative recovery such as extra-articular pathology with referred pain to the knee (spinal stenosis, neuropathy, ipsilateral hip disease), severe knee deformity.
• Untreated Osteoarthritis
• BMI > 40
• ASA class > III
• History of drug or alcohol abuse

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sensor Guided Tissue Balancing; Patients in this group will have the Verasense trial sensor device inserted, and the data collected electronically. The surgeon will use this data to intraoperatively align the knee according to the indications of the data.	Device: Verasense; Verasense will collect balancing data on all patients in this trial.
Placebo Comparator: Surgeon Guided Tissue Balancing; Patients in this group will have the Verasense trial sensor device inserted, and the data collected electronically. The computer displaying the data will be turned away from the surgeon, so that he is not able to use the sensor data, and must balance the knee with feel and visual estimation of balance.	Device: Verasense; Verasense will collect balancing data on all patients in this trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Overall Patient Satisfaction will be reported through various surveys.	Surgery to 12 months post-operative

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Collaborators: Orthosensor, Inc.
• Investigators: Principal Investigator: Mark Snyder, MD, TriHealth Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): April 1, 2019
• Study Completion (Anticipated): April 8, 2021

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): May 4, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 15-053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Yes, Orthosensor receives the data collected.