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Recruiting NCT05966519

ROSA Knee Intraoperative Planning Flexibility Study

— Observational Osteo Arthritis Knee Rheumatoid Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Total Knee Replacement (TKR).
Who it may be relevant to
Registry conditions: Osteo Arthritis Knee, Rheumatoid Arthritis. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • The mean absolute difference between X-Atlas image based pre-op plan & intra-op final plan [Time frame: Immediate post-operative]
Secondary outcome measures (5)
  • Pain, range of knee motion and functional performance [Time frame: Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months]
  • QOL [Time frame: Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months]
  • Rehabilitation record [Time frame: Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months]
  • Kinematic analysis [Time frame: Postoperative 12 months or 24 months]
  • Image review (CT/Radiograph) [Time frame: Preoperative, Discharge, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Japan · 1 center
  • Kyushu University Hospital — Fukuoka

Identifiers

NCT: NCT05966519 · CSA2022-29TDS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗