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NCT05966519 | RECRUITING | Osteo Arthritis Knee

ROSA Knee Intraoperative Planning Flexibility Study
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.

Condition or disease

Osteo Arthritis Knee

Rheumatoid Arthritis

Intervention/treatment

Total Knee Replacement (TKR)

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 Type : OBSERVATIONAL
Estimated Enrollment : 80 participants
Official Title : ROSA Knee Intraoperative Planning Flexibility on Japan Preferred Surgical Technique, a Single Center Prospective Study
Actual Study Start Date : 2024-01-05
Estimated Primary Completion Date : 2026-01
Estimated Study Completion Date : 2028-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 20 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
ROSA Knee Intraoperative Planning Flexibility Study

Location Details

NCT05966519

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Japan, Fukuoka

Kyushu University Hospital

Fukuoka, Fukuoka, Japan, 812-8582