Knee Pain ChronicNCT05787821
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
An observational study of Knee Pain Chronic and Osteoarthritis, Knee, run by Zimmer Biomet at 16 sites in United States.
Trial summary
The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Pain Chronic, Osteoarthritis, Knee, Rheumatoid Arthritis
- What is being tested?
- Total Knee Arthroplasty
- Type of treatment
- Medical device
- How many people
- 760 participants
- Where
- 16 sitesUnited States
- Study dates
- 28 Jun 2023to Jun 2035
- Phase
- Observational
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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be a subset of the US population electing to proceed with total knee arthroplasty irrespective of participation in the study and: 1) who will be receiving one or more of the components of interest as part of standard clinical care, 2) agree to participate by completing a study-specific informed consent form, and 3) who satisfy the inclusion/exclusion criteria.
Who may be able to join
- Patient is of legal age and skeletally mature
- Patient is willing and able to provide written Informed Consent by signing and dating the Institutional Review Board (IRB) / Ethics Committee (EC) approved Informed Consent document
- Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
- Independent of study participation, patient qualifies for either cemented or cementless primary or revision total knee arthroplasty (including salvage of previously failed surgical attempts) based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling
Who cannot join
- Patient is currently participating in any other surgical intervention or pain management study
- Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
- Patient has a mental or neurological condition who is unwilling or incapable of following postoperative care instructions
- Patient has a condition which would, in the judgment of the investigator, place the patient at undue risk or interfere with the conduct of the study
- Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
- Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty
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- Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
- Insufficient bone stock on femoral or tibial surfaces
- Neuropathic arthropathy
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
- A stable, painless arthrodesis in a satisfactory functional position
- Severe instability secondary to the absence of collateral ligament integrity
- Rheumatoid Arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
- Patient has a > 5˚ valgus deformity with a medial collateral ligament (MCL) insufficiency, and the surgeon intends to use the personalized alignment surgical technique
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
New Mexico Orthopaedic Associates
Albuquerque, New Mexico, 87110
University of Michigan
Ann Arbor, Michigan, 48109
Northside Hospital, Inc.
Atlanta, Georgia, 30342
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, 28207
UVA Health Orthopedic Center
Charlottesville, Virginia, 22903
Cleveland Clinic
Cleveland, Ohio, 44195
Syracuse Orthopaedic Specialists
DeWitt, New York, 13214
UT Health at Houston
Houston, Texas, 77030
Mississippi Sports Medicine and Orthopaedic Center
Jackson, Mississippi, 39202
U of L Health
Louisville, Kentucky, 40202
Duke University
Morrisville, North Carolina, 27560
NYU
New York, New York, 11016
Denver Hip & Knee, Inc.
Parker, Colorado, 80138
Mayo Clinic
Rochester, Minnesota, 55902
St. Francis Hospital & Heart Center
Roslyn, New York, 11576
Foundation for Orthopaedic Research & Education
Tampa, Florida, 33607
About this study
Official title: Persona® OsseoTi® Keel Compatibility Study-A Multicenter Cohort Study A Prospective, Post-market Clinical Follow-up Study to Demonstrate Safety, Performance and Clinical Benefits of the Persona Knee System Portfolio and Its Instrumentation
The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty
Read the detailed description
The study design is a prospective, multicenter data collection model of the 510(k) cleared Persona Total Knee System. The study will require each site to obtain institutional review board (IRB) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty (TKA). Investigators will collect clinical data for a required 5 years. Follow-up clinical visits include 3 months, 1, 2, 5, 7 and 10 years post-operatively.
Specific assessments include:
- Confirming the safety, performance and clinical benefits of the Persona total knee system and instrumentation in primary and revision TKA.
- Verifying that, under normal use, the performance and clinical benefits of this device and its instrumentation conform to those intended by the manufacturer by recording patient-reported clinical outcomes measures (PROMs) and radiographic outcomes (if available).
- Conditions
- Knee Pain Chronic, Osteoarthritis, Knee, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis, Varus Deformity
- Being tested
- Total Knee Arthroplasty
- Keywords
- Osteoarthritis, Total Knee Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee, Arthritis, Rheumatoid, Arthritis, Osteonecrosis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyDevice
Total knee replacement.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Cementless Femur Cementless Tibia Receives: Device: Total Knee Arthroplasty | |
| Cohort 2 | Cementless Femur Cementless Tibia Receives: Device: Total Knee Arthroplasty | |
| Cohort 3 | Cemented Femur Cemented Tibia Receives: Device: Total Knee Arthroplasty | |
| Cohort 4 | Cemented Femur Cemented Tibia Receives: Device: Total Knee Arthroplasty | |
| Cohort 5 | Cementless Femur Cemented Tibia Receives: Device: Total Knee Arthroplasty | |
| Cohort 6 | Cementless Femur Cemented Tibia Receives: Device: Total Knee Arthroplasty | |
| Cohort 7 | Cementless Femur Cemented Tibia Receives: Device: Total Knee Arthroplasty | |
| Cohort 8 | Cementless Femur Cemented Tibia Receives: Device: Total Knee Arthroplasty | |
| Cohort 9 | Cementless Femur Cementless Tibia Receives: Device: Total Knee Arthroplasty | |
| Cohort 10 | Cementless Femur Cementless Tibia Receives: Device: Total Knee Arthroplasty | |
| Cohort 11 | Intended to capture on-label configurations of newly cleared components not captured in cohorts 1-10. Receives: Device: Total Knee Arthroplasty | |
| Cohort 12 | Cementless Femur Cementless Tibia Cementless Patella Receives: Device: Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Knee Score (OKS)
A patient reported functional outcome score for knee arthroplasty. This score ranges from 0-48, with higher scores indicating a better outcome.
Measured: 5 years
Secondary outcomes (2)
EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure
A questionnaire completed by the patient and assesses his/her general health status. This score ranges from -0.573 to 1, with higher recorded scores indicating better overall health.
Measured: 5 years
Pain and Satisfaction Numeric Rating Scale (NRS)
Patients will rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"). Along with their pain rating, subjects will be asked to rate their current satisfaction with their surgery from "Very Dissatisfied" to "Very Satisfied".
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start28 Jun 2023
- Primary completion30 Jun 2026
- Study completionJun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain ChronicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 760 participants (estimated)
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
- NCT05787821
- Sponsor's protocol ID
- CMU2022-39K
- Status last verified
- Jul 2026
- First submitted
- 15 Mar 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No