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

NCT ID: NCT02717299

Last Updated: 2020-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2021-04-08

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.

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.

Conditions

Arthroplasty, Replacement, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Verasense

Intervention Type: DEVICE

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

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.

Group Type: PLACEBO_COMPARATOR

Verasense

Intervention Type: DEVICE

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

Interventions

Verasense

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthosensor, Inc.

INDUSTRY

Sponsor Role: collaborator

TriHealth Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Snyder, MD

Role: PRINCIPAL_INVESTIGATOR

TriHealth Inc.

Locations

Good Samarian Hospital

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

15-053

Identifier Type: -

Identifier Source: org_study_id