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ROSA Knee Intraoperative Planning Flexibility Study

NCT ID: NCT05966519

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-05

Study Completion Date

2028-01-31

Brief Summary

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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

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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.

Conditions

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Osteo Arthritis Knee Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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TKA with ROSA Knee

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

Total Knee Replacement (TKR)

Intervention Type DEVICE

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

Interventions

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Total Knee Replacement (TKR)

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yasuharu Nakashima

Role: PRINCIPAL_INVESTIGATOR

Kyushu University

Locations

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Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Noriko Sugawara

Role: CONTACT

Phone: +81-3-6402-6600

Email: [email protected]

Facility Contacts

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Shinya Kawahara

Role: primary

Other Identifiers

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CSA2022-29TDS

Identifier Type: -

Identifier Source: org_study_id