Degenerative Joint Disease of KneeNCT05037734
A Randomized Controlled Trial for Partial Knee Arthroplasty
A study testing Persona Partial Knee System in people with Degenerative Joint Disease of Knee and Osteoarthritis, run by Zimmer Biomet at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Degenerative Joint Disease of Knee, Osteoarthritis, Traumatic Arthritis
- What is being tested?
- Persona Partial Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2023to Dec 2030
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mississippi Sports Medicine and Orthopaedic Center
Jackson, Mississippi, 39202
About this study
Official title: A Post-Market, Multicenter, Randomized Controlled Trial of the ROSA® Partial Knee System for Unicompartmental Knee Arthroplasty
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.
Read the 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.
- Conditions
- Degenerative Joint Disease of Knee, Osteoarthritis, Traumatic Arthritis, Varus Deformity, Knee Pain Chronic
- Being tested
- Persona Partial Knee System
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persona Partial Knee SystemDevice
Unicompartmental Knee Replacement
| Study group | Role | What they receive |
|---|---|---|
| Robotic-Assisted UKA | Active comparator | Randomized participant will receive UKA via the ROSA Partial Knee System. Receives: Device: Persona Partial Knee System |
| Traditional/Conventional UKA | Active comparator | Randomized participant will receive the UKA via Conventional/Traditional UKA Methods. Receives: Device: Persona Partial Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Weeks
Secondary outcomes (7)
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.
Measured: 24 months
Evaluation of range of motion
Evaluation of knee flexion/extension pre-operatively and post-operatively
Measured: 24 months
Evaluation of Instability
Medial/Lateral and Anterior/Posterior instability measured from none to severe(>5mm).
Measured: 24 months
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).
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 Months
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.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study startJun 2023 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionDec 2030 (estimated)
Why it stopped: Relaunch at later date with updated product.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Joint Disease of KneeStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hillary Overholser, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037734
- Sponsor's protocol ID
- CMU2020-28CA
- Status last verified
- May 2022
- First submitted
- 20 Aug 2021
- Last updated
- 5 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market, Multicenter, Randomized Controlled Trial of the ROSA® Partial Knee System for Unicompartmental Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05037734
- Acronym / sponsor ID
- CMU2020-28CA
- Conditions
- Degenerative Joint Disease of Knee, Osteoarthritis, Traumatic Arthritis, Varus Deformity, Knee Pain Chronic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Relaunch at later date with updated product.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-Assisted UKA | Active comparator | Device: Persona Partial Knee SystemRandomized participant will receive UKA via the ROSA Partial Knee System. |
| Traditional/Conventional UKA | Active comparator | Device: Persona Partial Knee SystemRandomized participant will receive the UKA via Conventional/Traditional UKA Methods. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Persona Partial Knee SystemUnicompartmental Knee Replacement | Device | Robotic-Assisted UKA, Traditional/Conventional UKA |
Primary outcome
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.
7 secondary outcomes
Evaluation of Patient safety
Time frame: 24 months
Evaluation of range of motion
Time frame: 24 months
Evaluation of Instability
Time frame: 24 months
Patient Reported Outcome Measure (Oxford Knee Score)
Time frame: 24 months
Patient Reported Outcome Measure (KOOS-12)
Time frame: 24 months
Numeric Pain Rating Scale (NPRS)
Time frame: 24 Months
Subject Satisfaction
Time frame: 24 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hillary Overholser study director
Zimmer Biomet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Persona Partial Knee System in people with Degenerative Joint Disease of Knee and Osteoarthritis, run by Zimmer Biomet at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of implant position (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.