ROSA Knee Intraoperative Planning Flexibility Study

Recruiting

• Conditions: Rheumatoid Arthritis; Osteo Arthritis Knee
• Interventions: Device: Total Knee Replacement (TKR)

• Registration Number: NCT05966519
• Lead Sponsor: Zimmer Biomet

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-07-21
• Study First Submitted QC: 2023-07-21
• Study First Posted: 2023-07-28
• Study Start: 2024-01-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TKA with ROSA Knee	Total Knee Replacement (TKR)	Total Knee Arthroplasty (TKA) is conducted using with robotic surgical assistant (ROSA) system

Primary Outcome Measures

Name	Time	Method
The mean absolute difference between X-Atlas image based pre-op plan & intra-op final plan	Immediate post-operative	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kyushu University Hospital; 🇯🇵 Fukuoka, Japan