ROSA Knee Intraoperative Planning Flexibility Study (IntraOP)

ROSA Knee Intraoperative Planning Flexibility on Japan Preferred Surgical Technique, A Single Center Prospective Study

The purpose of this study is to verify that an orthopedic surgical assist robot (ROSA Knee System) can provide intraoperative adjustment of osteotomy angle and volume for total knee arthroplasty (TKA) based on feedbacks obtained from intraoperative soft tissue conditions. A total 80 cases will be enrolled at one study site with a postoperative follow-up period of 2 years.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis; Osteo Arthritis Knee
• Intervention / Treatment: Device: Total Knee Replacement (TKR)

Detailed Description

The objectives of the study are to document that ROSA Knee System can provide intraoperative planning adjustment based on feedbacks obtained by laxity as well as gaps to locally preferred surgeon's operative philosophy. This will also provide accuracy, intraoperative soft tissue release as well as patient outcome on locally preferred surgical technique.

The primary endpoint is defined as the mean absolute difference between X-Atlas image-based pre-op plan & intra-op final plan.

The secondary endpoints include Kinematic Analysis, EuroQol 5 dimensions (EQ-5D), Rehabilitation record, Knee Society Score (KSS) 2011, image assessment and Safety up to 2 years postoperatively.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Noriko Sugawara; Phone Number: +81-3-6402-6600; Email: noriko.sugawara@zimmerbiomet.com

Study Locations

• Japan
  • Fukuoka, Japan, 812-8582
    • Recruiting
    • Kyushu University Hospital
    • Contact: Shinya Kawahara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise of males and females who require primary total knee arthroplasty and satisfy the inclusion/exclusion criteria outlined in this section of the protocol. In order to avoid potential selection bias, each Investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary total knee arthroplasty using the commercially available Zimmer Biomet total knee systems. Eligible candidates who express interest in study participation will be offered Informed Consent.

Description

Inclusion Criteria:

• 20 years and over
• Skeletally matured
• Decision to have Total Knee Arthroplasty with ROSA Knee System being made independently and prior to recruitment into study
• Willing and able to complete scheduled follow-up evaluations as described in the study protocol
• Has participated in the informed consent process and is willing and able to sign an Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form

Exclusion Criteria:

• Has serious bone defect(s), which require(s) metallic augment, synthetic bone or allograft
• Is septic, has an active infection or has osteomyelitis at the affected joint
• Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery
• Has any concomitant disease which is likely to jeopardize the functioning or success of the implant
• Is known to be pregnant
• Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails
• Has a known sensitivity or allergy to one or more of the implanted materials

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TKA with ROSA Knee; Total Knee Arthroplasty (TKA) is conducted using with robotic surgical assistant (ROSA) system	Device: Total Knee Replacement (TKR); Damaged cartilage of knee due to degenerative disease is replaced with metallic and plastic protheses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mean absolute difference between X-Atlas image based pre-op plan & intra-op final plan	The mean absolute difference between X-Atlas image-based pre-op plan and intra-op final plan in order to demonstrate the ability of the system to allow for intra-operative adjustments	Immediate post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain, range of knee motion and functional performance	The Knee Society Score 2011, and Physical Exam to evaluate pain, range of knee motion and functional performance	Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months
QOL	Subject quality-of-life will be measured by the EuroQol 5 dimensions 5-level (EQ-5D-5L)	Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months
Rehabilitation record	Recovery of patient will be assessed by prescribed Rehabilitation record and compliance	Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months
Kinematic analysis	Kinematic analysis will be conducted to visualize postoperative knee motion	Postoperative 12 months or 24 months
Image review (CT/Radiograph)	Image review (CT/Radiograph) to assess the accuracy of the implant position, radiolucency, osteolysis, atrophy, hypertrophy, component migration, device fracture, heterotopic ossification, etc.	Preoperative, Discharge, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Yasuharu Nakashima, Kyushu University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CSA2022-29TDS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No