ROSA Knee Intraoperative Planning Flexibility Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorZimmer Biomet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Total Knee Replacement (TKR)
DeviceDamaged cartilage of knee due to degenerative disease is replaced with metallic and plastic protheses
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: TKA with ROSA Knee1 intervention
Trial outcomes
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
Time frame
Immediate post-operativeSecondary outcomes
1
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
Time frame
Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months2
QOL
Subject quality-of-life will be measured by the EuroQol 5 dimensions 5-level (EQ-5D-5L)
Time frame
Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months3
Rehabilitation record
Recovery of patient will be assessed by prescribed Rehabilitation record and compliance
Time frame
Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months4
Kinematic analysis
Kinematic analysis will be conducted to visualize postoperative knee motion
Time frame
Postoperative 12 months or 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov