ROSA Knee Intraoperative Planning Flexibility Study

Rheumatoid Arthritis Clinical Trial

— IntraOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05966519
• Other study ID #: CSA2022-29TDS
• Status: Recruiting
• Start date: January 5, 2024
• Est. completion date: July 2027

Study information

• Verified date: January 2024
• Source: Zimmer Biomet
• Contact: Noriko Sugawara
• Phone: +81-3-6402-6600
• Email: noriko.sugawara[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2027
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Rheumatoid Arthritis

Intervention

Device:
• Total Knee Replacement (TKR)
Damaged cartilage of knee due to degenerative disease is replaced with metallic and plastic protheses

Locations

Country	Name	City	State
Japan	Kyushu University Hospital	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Kinematic analysis	Kinematic analysis will be conducted to visualize postoperative knee motion	Postoperative 12 months or 24 months
Secondary	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