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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717299
Recruitment Status : Active, not recruiting
First Posted : March 23, 2016
Last Update Posted : May 4, 2020
Sponsor:
Collaborator:
Orthosensor, Inc.
Information provided by (Responsible Party):
TriHealth Inc.

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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Device: Verasense Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Making Sense Out of Total Knee Sensor Assisted Technology: A Randomized Control Trial
Actual Study Start Date : November 2015
Actual Primary Completion Date : April 2019
Estimated Study Completion Date : April 8, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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.




Primary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: Surgery to 12 months post-operative ]
    Overall Patient Satisfaction will be reported through various surveys.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717299


Locations
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United States, Ohio
Good Samarian Hospital
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
Orthosensor, Inc.
Investigators
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Principal Investigator: Mark Snyder, MD TriHealth Inc.
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Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02717299    
Other Study ID Numbers: 15-053
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Yes, Orthosensor receives the data collected.