Knee PainNCT03969654

ROSA Robot Used in Total Knee Replacement Post Market Study

A study testing PERSONA Total Knee, Vanguard Total Knee and NexGen Total Knee in people with Knee Pain and Chronic Osteoarthritis, run by Zimmer Biomet at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle
What is being tested?: PERSONA Total Knee, Vanguard Total Knee and NexGen Total Knee
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 181 participants
Where: 5 sitesUnited States
Study dates: 1 May 2020to 22 Sep 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patient is a minimum of 18 years of age
Independent of study participation, patient is a candidate for commercially available Persona, NexGen, and Vanguard knee components implanted in accordance with product labeling
Patient has participated in this study-related Informed Consent process
Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form
Patient is willing and able to complete scheduled study procedures and follow-up evaluations

Who cannot join

Patient is currently participating in any other surgical intervention studies or pain management studies
Patient has underwent contralateral UKA or TKA within the last 18 months
Hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum)
Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contracture, chronic severe dislocation)
Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
Patient has previously received partial or total knee arthroplasty for the ipsilateral knee

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Henry Ford Health System
Detroit, Michigan, 48202
OrthoVirginia Chippenham
North Chesterfield, Virginia, 23225
SIU School of Medicine
Springfield, Illinois, 62702
Vail-Summit Orthopaedics
Vail, Colorado, 81657
Cornerstone Orthopedics & Sports Medicine, a division of Orthopedic Centers of Colorado, LLC
Westminster, Colorado, 80023

Other trials in United States

About this study

Official title: ROSA Total Knee Post Market Study: Prospective Multicenter U.S. Study of the ROSA Total Knee System

This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. This clinical study will include Persona, NexGen, and Vanguard product families using the ROSA Total Knee Robotic System or conventional instrumentation. The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.

Read the detailed description

The primary objective of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.The assessments will include:Planned vs actual component positioning, workflow efficiency, patient safety based on incidence and frequency of adverse events, and clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.

Conditions: Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities, Rheumatoid Arthritis
Being tested: PERSONA Total Knee, Vanguard Total Knee, NexGen Total Knee
Medical subject headings: Genu Valgum, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PERSONA Total KneeDevice
Primary Total Knee Arthroplasty
Vanguard Total KneeDevice
Primary Total Knee Arthroplasty
NexGen Total KneeDevice
Primary Total Knee Arthroplasty

Study groups in NCT03969654
Study group	Role	What they receive
Robotic Assisted TKA	Active comparator	Robotic Assisted TKA Receives: Device: PERSONA Total Knee; Device: Vanguard Total Knee; Device: NexGen Total Knee
Conventional TKA	Active comparator	Conventional TKA Receives: Device: PERSONA Total Knee; Device: Vanguard Total Knee; Device: NexGen Total Knee

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Performance
EQ-5D Questionnaire: A questionnaire completed by the Patient and assesses his/her General Health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations. The scale is from 0-1, 0 being dead and 1 being the best possible score.
Measured: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Oxford
Oxford Knee Score: The Oxford Knee Score is a patient completed 12-question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The minimum score is 0 (most severe) and the maximum score is 48 points (least severe).
Measured: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Post-Operative Pain & Satisfaction
Post-Operative Pain \& Satisfaction Survey. The scale range for the level of satisfaction ranges is very satisfied, satisfied, uncertain, and unsatisfied.
Measured: 6 weeks, 3 months, and 1 year
Total Range of Motion
Total Range of Motion Change from Preop to 1 year. The scale includes the total range of motion (0 degrees of knee extension (fully straightened knee) and 135 degrees of knee flexion) from preop to 1-year postop
Measured: Pre-op (Baseline), 6 weeks, 3 months, and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202022 Sep 2023

First posted31 May 2019
Study start1 May 2020
Primary completion22 Sep 2023
Study completion22 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Knee PainStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 181 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03969654
Sponsor's protocol ID: CMU2018-34K
Status last verified: May 2024
First submitted: 29 May 2019
Last updated: 3 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Knee Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ROSA Total Knee Post Market Study: Prospective Multicenter U.S. Study of the ROSA Total Knee System
ClinicalTrials.gov ID: NCT03969654
Acronym / sponsor ID: CMU2018-34K
Conditions: Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities, Rheumatoid Arthritis
Study type: Interventional
Recruitment status: Completed
Enrolment: 181 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: 1 May 2020 (actual)
Primary completion: 22 Sep 2023 (actual)
Study completion: 22 Sep 2023 (actual)
First posted: 31 May 2019 (actual)
Results: Posted 3 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Robotic Assisted TKA	Active comparator	Device: PERSONA Total Knee, Device: Vanguard Total Knee, Device: NexGen Total KneeRobotic Assisted TKA
Conventional TKA	Active comparator	Device: PERSONA Total Knee, Device: Vanguard Total Knee, Device: NexGen Total KneeConventional TKA

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patient is a minimum of 18 years of age
Independent of study participation, patient is a candidate for commercially available Persona, NexGen, and Vanguard knee components implanted in accordance with product labeling
Patient has participated in this study-related Informed Consent process
Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form
Patient is willing and able to complete scheduled study procedures and follow-up evaluations

Key exclusion criteria (6 listed)

Patient is currently participating in any other surgical intervention studies or pain management studies
Patient has underwent contralateral UKA or TKA within the last 18 months
Hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum)
Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contracture, chronic severe dislocation)
Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)

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 Total KneePrimary Total Knee Arthroplasty	Device	Conventional TKA, Robotic Assisted TKA
Vanguard Total KneePrimary Total Knee Arthroplasty	Device	Conventional TKA, Robotic Assisted TKA
NexGen Total KneePrimary Total Knee Arthroplasty	Device	Conventional TKA, Robotic Assisted TKA

Primary outcome

Clinical Performance
Time frame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
EQ-5D Questionnaire: A questionnaire completed by the Patient and assesses his/her General Health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations. The scale is from 0-1, 0 being dead and 1 being the best possible score.
Oxford
Time frame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Oxford Knee Score: The Oxford Knee Score is a patient completed 12-question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The minimum score is 0 (most severe) and the maximum score is 48 points (least severe).
Post-Operative Pain & Satisfaction
Time frame: 6 weeks, 3 months, and 1 year
Post-Operative Pain \& Satisfaction Survey. The scale range for the level of satisfaction ranges is very satisfied, satisfied, uncertain, and unsatisfied.
Total Range of Motion
Time frame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Total Range of Motion Change from Preop to 1 year. The scale includes the total range of motion (0 degrees of knee extension (fully straightened knee) and 135 degrees of knee flexion) from preop to 1-year postop

Results and safety

Results posted to the registry on 3 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Robotic Assisted TKA	133	133
Conventional TKA	48	48

Primary outcome: Clinical Performance

Time frame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year. Mean (Standard Deviation). Unit: score on a scale

Measure	Robotic Assisted TKA n = 133	Conventional TKA n = 48
Preop	.540 (.268)	.442 (.256)
6 Week	.740 (.166)	.763 (.179)
3 Month	.826 (.137)	.842 (.128)
1 Year	.889 (.145)	.891 (.137)

Population analysed: Only subjects with valid EQ5D scores at the follow-up time points are included in the analysis.

Primary outcome: Oxford

Time frame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year. Mean (Standard Deviation). Unit: score on a scale

Measure	Robotic Assisted TKA n = 133	Conventional TKA n = 48
Preop	24.6 (9.2)	22.2 (8.2)
6 Week	32.0 (7.6)	32.5 (6.8)
3 Month	38.2 (6.8)	38.5 (6.9)
1 Year	42.4 (5.4)	41.2 (5.8)

Population analysed: Only subjects with valid Oxford scores at the follow-up time points are included in the analysis.

Primary outcome: Post-Operative Pain & Satisfaction

Time frame: 6 weeks, 3 months, and 1 year. Count of units. Unit: Knee

Measure	Robotic Assisted TKA n = 124	Conventional TKA n = 44
6 Week: Very Satisfied	80	32
6 Week: Satisfied	32	9
6 Week: Uncertain	12	2
6 Week: Unsatisfied	0	1
3 Month: Very Satisfied	89	34
3 Month: Satisfied	22	7
3 Month: Uncertain	9	1
3 Month: Unsatisfied	0	0

Population analysed: Only subjects with Patient Satisfaction form at the follow-up time points are included in the analysis.

Primary outcome: Total Range of Motion

Time frame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year. Mean (Standard Deviation). Unit: degrees

Measure	Robotic Assisted TKA n = 133	Conventional TKA n = 48
Preop	121.0 (13.9)	115.7 (16.2)
6 Week	114.5 (12.9)	111.4 (11.1)
3 Month	121.1 (11.0)	120.7 (9.7)
1 Year	122.7 (9.5)	120.4 (10.8)

Population analysed: Only subjects with valid ROM scores at the follow-up time points are included in the analysis.

Adverse events

Time frame: All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the date of study closure or the date of subject withdrawal for an average of 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Robotic Assisted TKA	7 of 133 (5.3%)	52 of 133 (39.1%)	0 of 133
Conventional TKA	1 of 48 (2.1%)	20 of 48 (41.7%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PERSONA Total Knee, Vanguard Total Knee and NexGen Total Knee in people with Knee Pain and Chronic Osteoarthritis, run by Zimmer Biomet at 5 sites 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

Yes. Results are posted in the registry (first posted 3 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Clinical Performance (time frame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03969654.

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 3 May 2024; AzTrials last refreshed its copy on 26 Oct 2026.