- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02717299
Making Sense Out of Total Knee Sensor Assisted Technology: A Randomized Control Trial
April 30, 2020 updated by: TriHealth Inc.
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45220
- Good Samarian Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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.
|
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.
|
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
Time Frame: Surgery to 12 months post-operative
|
Overall Patient Satisfaction will be reported through various surveys.
|
Surgery to 12 months post-operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Snyder, MD, TriHealth Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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