ROSA Knee Intraoperative Planning Flexibility Study

NCT05966519 | Recruiting FDA Device

• 1 other identifier: CSA2022-29TDS
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pain, range of knee motion and functional performance

  Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months

• QOL

  Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months

• Rehabilitation record

  Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months

• Kinematic analysis

  Postoperative 12 months or 24 months

• Image review (CT/Radiograph)

  Preoperative, Discharge, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months

Study Arms (1)

TKA with ROSA Knee

Total Knee Arthroplasty (TKA) is conducted using with robotic surgical assistant (ROSA) system

Device: Total Knee Replacement (TKR)

Interventions

Total Knee Replacement (TKR) DEVICE

Damaged cartilage of knee due to degenerative disease is replaced with metallic and plastic protheses

TKA with ROSA Knee

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Yasuharu Nakashima

  Kyushu University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noriko Sugawara

CONTACT

+81-3-6402-6600; noriko.sugawara@zimmerbiomet.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: July 28, 2023
• Study Start: January 5, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

JP (1)