Persona Revision Knee System Outcomes

Official title

Clinical Investigation to Demonstrate Performance, Safety and Clinical Benefits of the Persona Revision Knee System

Overview

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, 5, 7, and 10 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.

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.

Primary outcome measures

• Knee Society Clinical Rating System objective knee score (KS-KS) [Time frame: 2 years]

Secondary outcome measures (3)

• Incidence and frequency of adverse events. [Time frame: 2 years]
• Numeric Rating Scale (NRS) Pain Score [Time frame: 2 years]
• Knee Injury and Osteoarthritis Outcome Score Junior (KOOS-Jr) [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

• 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.
• 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):

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis or polyarthritis
• Collagen disorders, and/or avascular necrosis of the femoral condyle
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
• Moderate valgus, varus, or flexion deformities
• 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
• 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:

• An ulcer of the skin
• History of recurrent breakdown of the skin
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 16 centers

• Advanced Orthopaedic Specialists — Fayetteville
• Bowen Hefley Orthopedics — Little Rock
• Community Foundation Medical Group — Fresno
• Cornerstone Orthopaedics & Sports Medicine — Superior
• Orthopaedic Associates, Inc. — Evansville
• Jeff Yergler, LLC — Granger
• Arthroplasty Foundation Inc. — Louisville
• Ascension Providence Rochester Hospital — Rochester
• … and 8 more centers

Identifiers

NCT: NCT04821154 · CMG2019-13K

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗