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Active, not recruitingNCT05787821Updated Oct 19, 2026

Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

An observational study in Knee Pain Chronic, Osteoarthritis, Knee and Rheumatoid Arthritis, sponsored by Zimmer Biomet. Active, not recruiting at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Zimmer Biomet · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
760
Ages
18 Years and older
Sex
All
01

Study 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 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:

  1. Confirming the safety, performance and clinical benefits of the Persona total knee system and instrumentation in primary and revision TKA.
  2. 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).
02

Conditions studied

  • Knee Pain Chronic
  • Osteoarthritis, Knee
  • Rheumatoid Arthritis
  • Traumatic Arthritis
  • Polyarthritis
  • Varus Deformity
  • Valgus Deformity
  • Flexion Deformity of Knee
  • Avascular Necrosis

Keywords

  • Osteoarthritis
  • Total Knee Arthroplasty
03

In context

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's planned enrollment of 760 is above the median of 100 across 486 observational studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.

Browse Zimmer Biomet studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient is of legal age and skeletally mature
  2. Patient is willing and able to provide written by signing and dating the Institutional Review Board (IRB) / Ethics Committee (EC) approved Informed Consent document
  3. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
  4. 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

Exclusion criteria

Exclusion Criteria:

  1. Patient is currently participating in any other surgical intervention or pain management study
  2. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
  3. Patient has a mental or neurological condition who is unwilling or incapable of following postoperative care instructions
  4. 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
  5. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
  6. Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty
  7. Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
  8. Insufficient bone stock on femoral or tibial surfaces
  9. Neuropathic arthropathy
  10. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
  11. A stable, painless arthrodesis in a satisfactory functional position
  12. Severe instability secondary to the absence of collateral ligament integrity
  13. Rheumatoid Arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
  14. Patient has a > 5˚ valgus deformity with a medial collateral ligament (MCL) insufficiency, and the surgeon intends to use the personalized alignment surgical technique
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
760 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cohort 1

    Cementless Femur Cementless Tibia

    Device: Total Knee Arthroplasty

  • Cohort 2

    Cementless Femur Cementless Tibia

    Device: Total Knee Arthroplasty

  • Cohort 3

    Cemented Femur Cemented Tibia

    Device: Total Knee Arthroplasty

  • Cohort 4

    Cemented Femur Cemented Tibia

    Device: Total Knee Arthroplasty

  • Cohort 5

    Cementless Femur Cemented Tibia

    Device: Total Knee Arthroplasty

  • Cohort 6

    Cementless Femur Cemented Tibia

    Device: Total Knee Arthroplasty

  • Cohort 7

    Cementless Femur Cemented Tibia

    Device: Total Knee Arthroplasty

  • Cohort 8

    Cementless Femur Cemented Tibia

    Device: Total Knee Arthroplasty

  • Cohort 9

    Cementless Femur Cementless Tibia

    Device: Total Knee Arthroplasty

  • Cohort 10

    Cementless Femur Cementless Tibia

    Device: Total Knee Arthroplasty

  • Cohort 11

    Intended to capture on-label configurations of newly cleared components not captured in cohorts 1-10.

    Device: Total Knee Arthroplasty

  • Cohort 12

    Cementless Femur Cementless Tibia Cementless Patella

    Device: Total Knee Arthroplasty

Interventions

  • DeviceTotal Knee Arthroplasty

    Total knee replacement.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 years

Secondary outcomes

  1. 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.

    Time frame: 5 years

  2. 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".

    Time frame: 5 years

07

Study locations

16 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2023 to primary completion in Jun 2026, 36 months.

Of 220 observational studies under Osteoarthritis, Knee, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 61. This study's 36 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 15, 2023
First posted
Mar 28, 2023
StartActual
Jun 28, 2023
Primary completionActual
Jun 30, 2026
CompletionEst.
Jun 2035
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05787821
Lead sponsor
Zimmer Biomet
Responsible party
Sponsor
First posted
Mar 28, 2023
Start date
Jun 28, 2023
Primary completion
Jun 30, 2026
Completion
Jun 2035 (estimated)
Last update
Oct 19, 2026

Study contacts

Hillary Overholser
study director · Zimmer Biomet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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