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Persona Revision Knee System Outcomes

ConditionsArthroplasty ComplicationsInfectionKnee DiseaseKnee Osteoarthritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZimmer Biomet

About this trial

The study will evaluate the performance, clinical benefits and safety of the Persona Revision Knee System in patients who have received primary or revision total knee arthroplasty (TKA) treatment. This will be done using a multicenter, single-arm, consecutive series, retrospective cohort study with prospective follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female of at least 18 years of age at the time of screening.

Signed an institutional review board approved informed consent.

Willingness and ability to comply with the study procedures and visit schedules and ability to understand and follow oral and written post-operative care instructions.

Rheumatoid arthritis, osteoarthritis, traumatic arthritis or polyarthritis

Disqualifiers

An ulcer of the skin

History of recurrent breakdown of the skin

Use of steroids

Trial population

Patients in need of a primary or revision total knee procedure who receive Persona Revision Knee implants who meet all the inclusion criteria and none of the exclusion criteria.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Persona Revision Knee System

    Device

    Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.

Treatment groups

380 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Group A: 1) Revision Splined CCK1 intervention
Group B: 2) Revision Cemented CCK1 intervention
Group C: 3) Revision Splined PS/CPS1 intervention
Group D: 4) Revision Cemented PS/CPS1 intervention
Group E: 5) Revision Splined PS/CPS1 intervention
Group F: 6) Revision Cemented PS/CPS1 intervention
Group G: 7) Revision Cemented CCK with 5 Degree Primary Tibia1 intervention
Group H: 8) Primary Splined CCK/CPS/PS with 0 Degree Tibia1 intervention
Group I: 9) Primary Cemented CCK/PS/CPS with 0 Degree Tibia1 intervention
Group J: 10) Primary Cemented CCK/PS/CPS with 5 Degree Primary Tibia0 interventions
Group K: 11) Infection Cases0 interventions

Trial outcomes

Primary outcomes

1

Knee Society Clinical Rating System objective knee score (KS-KS)

The primary endpoint for this study will be performance assessed by improvement in the 1989 Knee Society Clinical Rating System (KS) objective knee score (KS-KS) from baseline to 2 years (as evaluated using the overall group mean showing at least the minimal clinically important difference \[MCID\] of 5.4 points) The Knee Society objective knee score (KS-KS) assesses the knee joint by awarding points for pain, stability, and range of motion, with a minimum possible score of 0 and maximum possible score of 100. As described in Insall et al. (1989), "100 points will be obtained by a well-aligned knee prosthesis with no pain, \[at least 121\] degrees of motion, and negligible anteroposterior and mediolateral instability."

Time frame
2 years

Secondary outcomes

1

Incidence and frequency of adverse events.

Safety of the device will be assessed by evaluating the incidence and frequency of adverse events including (re-)revision of any component during the study in accordance with Regulation (EU) 2017/745 - Medical Device Regulation (MDR) Article 80(2) as well as Medical Devices Coordination Group (MDCG) 2020-10/1.

Time frame
2 years
2

Numeric Rating Scale (NRS) Pain Score

Performance and clinical benefits will be assessed by evaluating improvements in patient reported outcome measures (PROMs) of the Numeric Rating Scale (NRS) pain scores from baseline to 2 years. The Numeric Rating Scale (NRS) pain is scored on a scale of 0 to 10. A score of 0 indicates that the patient is experiencing no pain in their knee joint while a score of 10 indicates that the patient is experiencing the worst possible pain in their knee joint.

Time frame
2 years
3

Knee Injury and Osteoarthritis Outcome Score Junior (KOOS-Jr)

Performance and clinical benefits will be assessed by evaluating improvements in patient reported outcome measures (PROMs) for the Knee Injury and Osteoarthritis Outcome Score Junior (KOOS-Jr) subscale scores from baseline to 2 years. The Knee Injury and Osteoarthritis Outcome Score Junior (KOOS-Jr) is scored on a scale of 0 to 100. A score of 100 indicates that a patient is experiencing perfect knee health while a score of 0 indicates that a patient is experiencing total knee disability.

Time frame
2 years

Other outcomes

1

Radiographic Imaging

Exploratory outcomes will include the evaluation of radiographic imaging as required for adverse event/complication reporting purposes with focus on the following parameters: radiolucency lines, component migration/subsidence, osteolysis, and localized osteopenia.

Time frame
2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zimmer Biomet

Lead sponsor

Source ClinicalTrials.gov
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