A Prospective Study to Evaluate Robot Assisted Total Knee Replacement Outcomes

Primary Osteoarthritis of Knee Nos Clinical Trial

Official title:

A Prospective Study to Examine Patient Satisfaction, Function, and Limb Alignment Outcomes for Mako Versus Non-Mako Total Knee Replacements

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03523897
• Other study ID #: VirtuaHealth-Mako
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2022
• Source: Virtua Health, Inc.
• Contact: Jeremy K Reid, MD
• Phone: 917-763-6790
• Email: jreid[@]reconstructiveortho.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee
• Primary Osteoarthritis of Knee Nos

Intervention

Procedure:
• Robot Assisted Total Knee Replacement
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
• Traditional Total Knee Replacement
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

Locations

Country	Name	City	State
United States	Virtua Joint Replacement Institute	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Virtua Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Up to 5 years postoperatively
Secondary	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)	Up to 5 years postoperatively
Secondary	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.	Up to 5 years postoperatively
Secondary	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.	6 weeks postoperatively