Clinical trial NCT04821154: Persona Revision Knee System Outcomes
Official title: Clinical Investigation to Demonstrate Performance, Safety and Clinical Benefits of the Persona Revision Knee System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthroplasty Complications
Infection
Knee Disease
Knee Osteoarthritis
Keywords: Revision
Total Knee
Medical Device
Safety
Performance
Primary
Clinical Benefits
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2021-03-29
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Knee Society Clinical Rating System objective knee score (KS-KS)
timeFrame: 2 years
Secondary outcomes:
measure: Incidence and frequency of adverse events.
timeFrame: 2 years
measure: Numeric Rating Scale (NRS) Pain Score
timeFrame: 2 years
measure: Knee Injury and Osteoarthritis Outcome Score Junior (KOOS-Jr)
timeFrame: 2 years
Other outcomes:
measure: Radiographic Imaging
timeFrame: 2 years
Locations:
city: Fayetteville
country: United States
facility: Advanced Orthopaedic Specialists
state: Arkansas
city: Little Rock
country: United States
facility: Bowen Hefley Orthopedics
state: Arkansas
city: Fresno
country: United States
facility: Community Foundation Medical Group
state: California
city: Superior
country: United States
facility: Cornerstone Orthopaedics & Sports Medicine
state: Colorado
city: Evansville
country: United States
facility: Orthopaedic Associates, Inc.
state: Indiana
city: Granger
country: United States
facility: Jeff Yergler, LLC
state: Indiana
city: Louisville
country: United States
facility: Arthroplasty Foundation Inc.
state: Kentucky
city: Rochester
country: United States
facility: Ascension Providence Rochester Hospital
state: Michigan
city: Southfield
country: United States
facility: Michigan Orthopaedic Surgeons, PLLC
state: Michigan
city: Bloomington
country: United States
facility: TRIA Orthopaedic Center Research Institute
state: Minnesota
city: Columbia
country: United States
facility: Thomas Aleto MD, PC
state: Missouri
city: Chester
country: United States
facility: Orthopaedic Research Institute of New Jersey
state: New Jersey
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Oregon City
country: United States
facility: ROC Orthopedics
state: Oregon
city: Lancaster
country: United States
facility: Penn Medicine/ Lancaster General Health
state: Pennsylvania
city: Wauwatosa
country: United States
facility: Ortopedic Surgeons of Wisconsin, SC
state: Wisconsin
Study officials:
affiliation: Zimmer Biomet
name: Charles Jaggard
role: STUDY_DIRECTOR
References: