- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05037734
A Randomized Controlled Trial for Partial Knee Arthroplasty
A Post-Market, Multicenter, Randomized Controlled Trial of the ROSA® Partial Knee System for Unicompartmental Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sites will enroll participants into two separate arms for this study (rUKA and Conventional Instrumentation), following the assigned randomization. Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for participation in the study and will be pre-screened for participation in the informed consent process.
The primary objective of this study is to evaluate and compare the accuracy of the ROSA® Partial Knee System in regards to implant placement with that of traditional instrumentation. This will include the assessment of the planned vs. actual component positioning.
Secondary Objectives include the evaluation of safety and efficacy of this system and will include the assessment of common adverse events, physical exam findings, radiologic results and patient reported outcome measures.
Data collection will occur at the following intervals: Pre-operative, Operative, 6-weeks, 3-months, 1-year, and 2-years. Enrollment for the study is anticipated to last approximately 12-18 months. Allowing for 24 months of follow-up, the total estimated study time to final-patient final-visit will be approximately 42 months.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Mississippi
-
Jackson, Mississippi, United States, 39202
- Mississippi Sports Medicine and Orthopaedic Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient meets the approved indications for use in accordance with product labeling for both the Persona Partial Knee System and the ROSA® Partial Knee System.
- Body mass index ≤40 kg/m2
- Patient is of legal age and skeletally mature
- Patient is willing and able to provide informed consent.
- Patient is willing to be randomized into one of two study groups of UKA performed using ROSA® and UKA using Conventional Instrumentation
- Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol.
- Patient qualifies for primary UKA based on investigator's clinical judgement and has an intact anterior cruciate ligament.
- Independent of study participation, patient is a candidate for the commercially available Persona Partial Knee System.
Exclusion Criteria:
- Independent of study participation, patient meets any of the contraindications for use in accordance with product labeling of the Persona Partial Knee System and/or the ROSA® Partial Knee System.
- Orthopaedic procedure or pain management study of any joint within the last or next 6 months; furthermore, bilateral enrollment is excluded in this study.
- Prior ACL Repair
- Moderate to severe patello-femoral arthritis, that in the opinion of the investigator, would require patella-femoral arthroplasty.
- Patient is unwilling to sign the Informed Consent.
- Would, in the investigator's opinion, be unwilling or unable to comply with the postoperative care instructions or study follow-up schedule.
- Patient is considered a member of a protected/vulnerable population (Pregnant, prisoner, mentally incompetent, etc.).
- Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation.
- Patient has a condition which would, in the judgement of the investigator, place the patient at undue risk or interfere with the conduct of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Robotic-Assisted UKA
Randomized participant will receive UKA via the ROSA Partial Knee System.
|
Unicompartmental Knee Replacement
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Active Comparator: Traditional/Conventional UKA
Randomized participant will receive the UKA via Conventional/Traditional UKA Methods.
|
Unicompartmental Knee Replacement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of implant position
Time Frame: 6 Weeks
|
To compare and evaluate the accuracy of implant position of robotic-arm surgical assistant (ROSA® Partial Knee System) with that of conventional instrumentation (Traditional UKA).
Accuracy of the Implemented Plan will be evaluated by assessing Implant alignment post-operatively for participants enrolled for both Conventional Instrumentation and the ROSA® Partial Knee System.
|
6 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Patient safety
Time Frame: 24 months
|
Frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.
|
24 months
|
Evaluation of range of motion
Time Frame: 24 months
|
Evaluation of knee flexion/extension pre-operatively and post-operatively
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24 months
|
Evaluation of Instability
Time Frame: 24 months
|
Medial/Lateral and Anterior/Posterior instability measured from none to severe(>5mm).
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24 months
|
Patient Reported Outcome Measure (Oxford Knee Score)
Time Frame: 24 months
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A questionnaire completed by the patient consisting of twelve questions that utilize a 5-point Likert scoring system (0 - 4) resulting in a score ranging from 0 (worst) to 48 (best).
|
24 months
|
Patient Reported Outcome Measure (KOOS-12)
Time Frame: 24 months
|
A questionnaire completed by the patient consisting of a 12-item short form of the original 42-item Knee Injury Osteoarthritis Outcome Score (KOOS), and will be used to measure the patients' perception of pain, function, and knee-related quality of life
|
24 months
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 24 Months
|
An 11-point NPRS is a patient self-completed reported outcome and will be used to assess the current level of pain for the affected hip.
On this scale, 0 will indicate no pain and 10 will indicate the worst pain imaginable
|
24 Months
|
Subject Satisfaction
Time Frame: 24 Months
|
A questionnaire consisting of a single satisfaction question in regard to the subjects knee replacement.
Answers will include the following: Very Dissatisfied, Dissatisfied, Neutral, Satisfied, Very Satisfied.
|
24 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hillary Overholser, Zimmer Biomet
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMU2020-28CA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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