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

NCT02717299 | Unknown

• 1 other identifier: 15-053
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

  Overall Patient Satisfaction will be reported through various surveys.

  Surgery to 12 months post-operative

Study Arms (2)

Sensor Guided Tissue Balancing

EXPERIMENTAL

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

Surgeon Guided Tissue Balancing

PLACEBO COMPARATOR

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

Interventions

Verasense DEVICE

Verasense will collect balancing data on all patients in this trial.

Sensor Guided Tissue Balancing; Surgeon Guided Tissue Balancing

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead
• Orthosensor, Inc.: collaborator

Study Sites (1)

Good Samarian Hospital

Cincinnati, Ohio, 45220, United States

Location

Study Officials

• Mark Snyder, MD

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 23, 2016
• Study Start: November 1, 2015
• Primary Completion: April 1, 2019
• Study Completion: April 8, 2021
• Last Updated: May 4, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)