Back to resultsA Randomized Controlled Trial for Partial Knee Arthroplasty
Primary Purpose
Degenerative Joint Disease of Knee, Osteoarthritis, Traumatic Arthritis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Persona Partial Knee System
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Joint Disease of Knee
Eligibility Criteria
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.
Sites / Locations
- Mississippi Sports Medicine and Orthopaedic Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Robotic-Assisted UKA
Traditional/Conventional UKA
Arm Description
Randomized participant will receive UKA via the ROSA Partial Knee System.
Randomized participant will receive the UKA via Conventional/Traditional UKA Methods.
Outcomes
Primary Outcome Measures
Accuracy of implant position
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.
Secondary Outcome Measures
Evaluation of Patient safety
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.
Evaluation of range of motion
Evaluation of knee flexion/extension pre-operatively and post-operatively
Evaluation of Instability
Medial/Lateral and Anterior/Posterior instability measured from none to severe(>5mm).
Patient Reported Outcome Measure (Oxford Knee Score)
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).
Patient Reported Outcome Measure (KOOS-12)
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
Numeric Pain Rating Scale (NPRS)
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
Subject Satisfaction
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05037734
Brief Title
A Randomized Controlled Trial for Partial Knee Arthroplasty
Official Title
A Post-Market, Multicenter, Randomized Controlled Trial of the ROSA® Partial Knee System for Unicompartmental Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Relaunch at later date with updated product.
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
June 2030 (Anticipated)
Study Completion Date
December 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This is a prospective, multi-center, two-arm, randomized, controlled post-market study to evaluate and compare the clinical accuracy of component placement in robotic-assisted UKA and that of traditional methods.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Joint Disease of Knee, Osteoarthritis, Traumatic Arthritis, Varus Deformity, Knee Pain Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The participant will be randomized into one of the two available study arms, and will be blinded from treatment until surgery has occurred.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robotic-Assisted UKA
Arm Type
Active Comparator
Arm Description
Randomized participant will receive UKA via the ROSA Partial Knee System.
Arm Title
Traditional/Conventional UKA
Arm Type
Active Comparator
Arm Description
Randomized participant will receive the UKA via Conventional/Traditional UKA Methods.
Intervention Type
Device
Intervention Name(s)
Persona Partial Knee System
Intervention Description
Unicompartmental Knee Replacement
Primary Outcome Measure Information:
Title
Accuracy of implant position
Description
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.
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
Evaluation of Patient safety
Description
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.
Time Frame
24 months
Title
Evaluation of range of motion
Description
Evaluation of knee flexion/extension pre-operatively and post-operatively
Time Frame
24 months
Title
Evaluation of Instability
Description
Medial/Lateral and Anterior/Posterior instability measured from none to severe(>5mm).
Time Frame
24 months
Title
Patient Reported Outcome Measure (Oxford Knee Score)
Description
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).
Time Frame
24 months
Title
Patient Reported Outcome Measure (KOOS-12)
Description
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
Time Frame
24 months
Title
Numeric Pain Rating Scale (NPRS)
Description
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
Time Frame
24 Months
Title
Subject Satisfaction
Description
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.
Time Frame
24 Months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hillary Overholser
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Mississippi Sports Medicine and Orthopaedic Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Randomized Controlled Trial for Partial Knee Arthroplasty
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