Back to resultsA Prospective Study to Evaluate Robot Assisted Total Knee Replacement Outcomes
Primary Purpose
Primary Osteoarthritis of Knee Nos
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robot Assisted Total Knee Replacement
Traditional Total Knee Replacement
Sponsored by
About this trial
This is an interventional basic science trial for Primary Osteoarthritis of Knee Nos
Eligibility Criteria
Inclusion Criteria:
- Age 18 or older
- Diagnosed with primary osteoarthritis and cleared to undergo total knee arthroplasty at the Virtua JRI
- Willing to provide informed consent, participate in study, and comply with study protocol
Exclusion Criteria:
- Pregnant or contemplating pregnancy prior to surgery;
- Worker's compensation or personal injury related to knee (clinical outcomes have been shown to be less predictable and often poorer in this patient group; there may also exist potential issues with reimbursement)
- Post-traumatic arthropathy (clinical outcomes have been shown to be less predictable; pre-operative deformity and risk factors are greater and difficult to propensity-match between groups)
- Self-pay patients or patients whose insurance are known to typically decline reimbursement for preoperative CT scans
Sites / Locations
- Virtua Joint Replacement InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Robot Assisted Total Knee Replacement
Traditional Total Knee Replacement
Arm Description
In addition to expert judgment and hand-eye coordination, the surgeon also relies on a robot in making cuts within the pre-determined diseased areas of the joints and placing the implants. This is made possible by uploading 3-dimensional (3D) images of the knee joints into the robot prior to surgery. The robot uses these 3D images to guide the surgeon during the procedure. The 3D images are obtained from a computerized tomography (CT) scan that combines a series of X-ray images taken from different angles to create cross-sectional images of the bones.
The traditional method where the surgeon employs mechanical guides, expert judgment, and natural hand-eye coordination in making the necessary cuts to prepare the bone for the implant as well as in placing the implant.
Outcomes
Primary Outcome Measures
Patient reported Forgotten Joint Score (FJS)
The FJS is a self-completed 12-item questionnaire used to assess patients' awareness of their artificial joint during activities of daily living on an awareness scale of 0 (never) to 4 (mostly)
Secondary Outcome Measures
Patient reported Knee injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a knee-specific instrument used to evaluate short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 42 questions in 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL)
Patient reported Veterans Rand 12-item Health Survey Score (VR-12)
The VR-12 is a 12-item questionnaire corresponding to eight principal physical and mental health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health.
The mechanical alignment of the post-operative limb
The mechanical alignment of the entire post-operative limb will be measured at 6 weeks by long-limb radiograph cassettes and compared to the pre-operative plan for accuracy and deviation less than or greater than 3 degrees from the intended target. From each treatment group, the percentage of patients with radiographic outliers (deviation greater that 3 degrees from the expected implant placement) will be compared.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03523897
Brief Title
A Prospective Study to Evaluate Robot Assisted Total Knee Replacement Outcomes
Official Title
A Prospective Study to Examine Patient Satisfaction, Function, and Limb Alignment Outcomes for Mako Versus Non-Mako Total Knee Replacements
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virtua Health, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to see if outcomes for patients that receive the traditional total knee replacement surgical technique are different than the outcomes for patients that receive robot-assisted total knee replacement. The outcomes we will be tracking include:
Patients' self-reported awareness of their artificial joints during activities of daily living;
Patient's self-reported pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life;
Patients' self-reported general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health;
The accuracy of implant placement and limb alignment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Osteoarthritis of Knee Nos
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
248 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robot Assisted Total Knee Replacement
Arm Type
Active Comparator
Arm Description
In addition to expert judgment and hand-eye coordination, the surgeon also relies on a robot in making cuts within the pre-determined diseased areas of the joints and placing the implants. This is made possible by uploading 3-dimensional (3D) images of the knee joints into the robot prior to surgery. The robot uses these 3D images to guide the surgeon during the procedure. The 3D images are obtained from a computerized tomography (CT) scan that combines a series of X-ray images taken from different angles to create cross-sectional images of the bones.
Arm Title
Traditional Total Knee Replacement
Arm Type
Active Comparator
Arm Description
The traditional method where the surgeon employs mechanical guides, expert judgment, and natural hand-eye coordination in making the necessary cuts to prepare the bone for the implant as well as in placing the implant.
Intervention Type
Procedure
Intervention Name(s)
Robot Assisted Total Knee Replacement
Intervention Description
A robotic-assisted surgical procedure to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints
Intervention Type
Procedure
Intervention Name(s)
Traditional Total Knee Replacement
Intervention Description
A surgical procedure using mechanical guides to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints
Primary Outcome Measure Information:
Title
Patient reported Forgotten Joint Score (FJS)
Description
The FJS is a self-completed 12-item questionnaire used to assess patients' awareness of their artificial joint during activities of daily living on an awareness scale of 0 (never) to 4 (mostly)
Time Frame
Up to 5 years postoperatively
Secondary Outcome Measure Information:
Title
Patient reported Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
The KOOS is a knee-specific instrument used to evaluate short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 42 questions in 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL)
Time Frame
Up to 5 years postoperatively
Title
Patient reported Veterans Rand 12-item Health Survey Score (VR-12)
Description
The VR-12 is a 12-item questionnaire corresponding to eight principal physical and mental health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health.
Time Frame
Up to 5 years postoperatively
Title
The mechanical alignment of the post-operative limb
Description
The mechanical alignment of the entire post-operative limb will be measured at 6 weeks by long-limb radiograph cassettes and compared to the pre-operative plan for accuracy and deviation less than or greater than 3 degrees from the intended target. From each treatment group, the percentage of patients with radiographic outliers (deviation greater that 3 degrees from the expected implant placement) will be compared.
Time Frame
6 weeks postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 or older
Diagnosed with primary osteoarthritis and cleared to undergo total knee arthroplasty at the Virtua JRI
Willing to provide informed consent, participate in study, and comply with study protocol
Exclusion Criteria:
Pregnant or contemplating pregnancy prior to surgery;
Worker's compensation or personal injury related to knee (clinical outcomes have been shown to be less predictable and often poorer in this patient group; there may also exist potential issues with reimbursement)
Post-traumatic arthropathy (clinical outcomes have been shown to be less predictable; pre-operative deformity and risk factors are greater and difficult to propensity-match between groups)
Self-pay patients or patients whose insurance are known to typically decline reimbursement for preoperative CT scans
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy K Reid, MD
Phone
917-763-6790
Email
jreid@reconstructiveortho.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Reid, MD
Organizational Affiliation
Virtua Joint Replacement Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virtua Joint Replacement Institute
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Reid, MD
Phone
609-267-9400
Email
jreid@reconstructiveortho.com
First Name & Middle Initial & Last Name & Degree
Jeremy Reid, MD
First Name & Middle Initial & Last Name & Degree
Scott Schoifet, MD
First Name & Middle Initial & Last Name & Degree
Rajesh Jain, MD
First Name & Middle Initial & Last Name & Degree
Manny Porat, MD
First Name & Middle Initial & Last Name & Degree
Gregory Klingenstein, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Plan to pblish study outcomes in a relevant orthopedic journal
Learn more about this trial
A Prospective Study to Evaluate Robot Assisted Total Knee Replacement Outcomes
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