Persona Revision Knee System Outcomes

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female of at least 18 years of age at the time of screening. 2. Signed an institutional review board approved informed consent. 3. 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. 4. Previous medical diagnosis/ history of at least one of the following conditions requiring treatment using the Persona Revision Knee System within a pre-specified study variant configuration (cohort), in accordance with the instructions for use (IFU): 1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis or polyarthritis. 2. Collagen disorders, and/or avascular necrosis of the femoral condyle. 3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. 4. Moderate valgus, varus, or flexion deformities. 5. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. 5. A pre-operative Knee Society Knee Score (objective assessment) ≤ 80.

Exclusion Criteria:

1) Presence of clinically observed active or suspected latent infection in the affected joint at the time of procedure. 3) Presence of of local/systemic/distant focal infection that may affect or hematogenously spread to the prosthetic joint. 4) Skeletal immaturity or insufficient bone stock on femoral or tibial surfaces which cannot provide adequate support and/or fixation to the prosthesis. 5) Diagnosed with neuropathic arthropathy, osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb. 6) Presence of a stable, painless arthrodesis in a satisfactory functional position in the affected joint. 7) Severe instability of the affected joint secondary to the absence of collateral ligament integrity. 8) Diagnosis of rheumatoid arthritis in conjunction with any of the following at the time of screening: 1. An ulcer of the skin. 2. History of recurrent breakdown of the skin. 3. Use of steroids. 9) Patient requires simultaneous bilateral knee surgery for treatment of diagnosed condition. 10) Pregnant or women planning to become pregnant during the time they will be participating in the study. 11) Any documented clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening which, in the opinion of the Investigator, could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study procedure. 12) Any patient who is institutionalized, or with a known drug or alcohol dependence currently or within the last year.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04821154
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Zimmer Biomet
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Charles Jaggard
Principal Investigator Affiliation	Zimmer Biomet
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Arthroplasty Complications, Infection, Knee Disease, Knee Osteoarthritis

Additional Details

Under study are the Persona® Revision Knee System (K181947 and K191625) implants and instrumentation, and any compatible devices being used in conjunction according to the Instructions for Use. This will be accomplished by retrospectively identifying patients who underwent primary or revision TKA with this system and inviting them to participate in prospective data collection at 1, 2, 3, 4, and 5-years postoperative follow-up. As the device was not available for commercial use until late 2019, the retrospective portion will involve those activities that occurred per standard of care for participants. 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). A maximum of 20 sites will contribute to this study. There will be a maximum of 380 patients enrolled in the study.

Arms & Interventions

Arms

: 1) Revision Splined CCK

Patients who were implanted with a splined tibial stem, 0 degree Persona Revision tibial component, constrained condylar knee (CCK) articular surface, Persona Revision femoral component, and splined femoral stem.

: 2) Revision Cemented CCK

Patients who were implanted with a cemented tibial stem, 0 degree Persona Revision tibial component, CCK articular surface, Persona Revision femoral component, and cemented femoral stem.

: 3) Revision Splined PS/CPS

Patients who were implanted with a splined tibial stem, 0 degree Persona Revision tibial component, posterior stabilized/constrained posterior stabilized (PS/CPS) articular surface, Persona Revision femoral component, and splined femoral stem.

: 4) Revision Cemented PS/CPS

Patients who were implanted with a cemented tibial stem, 0 degree Persona Revision tibial component, PS/CPS articular surface, Persona Revision femoral component, and cemented femoral stem.

: 5) Revision Splined PS/CPS

Patients who were implanted with a splined tibial stem, 0 degree Persona Revision tibial component, PS/CPS articular surface, Persona primary PS femoral component, with no femoral stem.

: 6) Revision Cemented PS/CPS

Patients who were implanted with a cemented tibial stem, 0 degree Persona Revision tibial component, PS/CPS articular surface, Persona primary PS femoral component, with no femoral stem.

: 7) Revision Cemented CCK with 5 Degree Primary Tibia

Patients who were implanted with a cemented tibial stem, 5 degree Persona primary tibial component, CCK articular surface, Persona Revision femoral component, and cemented femoral stem.

: 8) Primary Splined CCK/CPS/PS with 0 Degree Tibia

Patients with a primary implant (non-revision case) who were implanted with a splined tibial stem, 0 degree Persona Revision tibial component, CCK/PS/CPS articular surface, Persona Revision femoral component, and splined femoral stem.

: 9) Primary Cemented CCK/PS/CPS with 0 Degree Tibia

Patients with a primary implant (non-revision case) who were implanted with a cemented tibial stem, 0 degree Persona Revision tibial component, CCK/PS/CPS articular surface, Persona Revision femoral component, and cemented femoral stem.

: 10) Primary Cemented CCK/PS/CPS with 5 Degree Primary Tibia

Patients with a primary implant (non-revision case) who were implanted with a cemented tibial stem, 5 degree Persona primary tibial component, CCK/PS/CPS articular surface, Persona Revision femoral component, and cemented femoral stem.

: 11) Infection Cases

Any configuration of PRK components used for end stage (non-temporary) treatment

Interventions

Device: - Persona Revision Knee System

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Advanced Orthopaedic Specialists, Fayetteville 4110486, Arkansas 4099753

Status

Recruiting

Address

Advanced Orthopaedic Specialists

Fayetteville 4110486, Arkansas 4099753, 72703

Site Contact

Sydney Dale

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