A Prospective Study to Evaluate Robot Assisted Total Knee Replacement Outcomes

Not Applicable

• Conditions: Primary Osteoarthritis of Knee Nos
• Interventions: Procedure: Traditional Total Knee Replacement; Procedure: Robot Assisted Total Knee Replacement

• Registration Number: NCT03523897
• Lead Sponsor: Virtua Health, Inc.

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:

1. Patients' self-reported awareness of their artificial joints during activities of daily living;

2. Patient's self-reported pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life;

3. 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;

4. The accuracy of implant placement and limb alignment

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-13
• Study Start: 2018-04-20
• Study First Submitted QC: 2018-05-01
• Study First Posted: 2018-05-14
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-26
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

1. Age 18 or older
2. Diagnosed with primary osteoarthritis and cleared to undergo total knee arthroplasty at the Virtua JRI
3. Willing to provide informed consent, participate in study, and comply with study protocol

Exclusion Criteria

1. Pregnant or contemplating pregnancy prior to surgery;
2. 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)
3. 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)
4. Self-pay patients or patients whose insurance are known to typically decline reimbursement for preoperative CT scans

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Total Knee Replacement	Traditional Total Knee Replacement	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.
Robot Assisted Total Knee Replacement	Robot Assisted Total Knee Replacement	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.

Primary Outcome Measures

Name	Time	Method
Patient reported Forgotten Joint Score (FJS)	Up to 5 years postoperatively	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

Name	Time	Method
Patient reported Veterans Rand 12-item Health Survey Score (VR-12)	Up to 5 years postoperatively	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	6 weeks postoperatively	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.
Patient reported Knee injury and Osteoarthritis Outcome Score (KOOS)	Up to 5 years postoperatively	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)

Trial Locations

Locations (1)

Virtua Joint Replacement Institute; 🇺🇸 Voorhees, New Jersey, United States