Persona Revision Knee System Outcomes

Zimmer Biomet

Status: Enrolling

Conditions: Infection; Arthroplasty Complications; Knee Disease; Knee Osteoarthritis

Treatments: Device: Persona Revision Knee System

Study type: Observational

Funder types: Industry

Identifiers

NCT04821154

CMG2019-13K

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

2. Presence of of local/systemic/distant focal infection that may affect or hematogenously spread to the prosthetic joint.

3. Skeletal immaturity or insufficient bone stock on femoral or tibial surfaces which cannot provide adequate support and/or fixation to the prosthesis.

4. Diagnosed with neuropathic arthropathy, osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb.

5. Presence of a stable, painless arthrodesis in a satisfactory functional position in the affected joint.

6. Severe instability of the affected joint secondary to the absence of collateral ligament integrity.

7. 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 design

380 participants in 11 patient groups

1) Revision Splined CCK

Description:

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.

Treatment:

Device: Persona Revision Knee System

2) Revision Cemented CCK

Description:

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.

Treatment:

Device: Persona Revision Knee System

3) Revision Splined PS/CPS

Description:

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.

Treatment:

Device: Persona Revision Knee System

4) Revision Cemented PS/CPS

Description:

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.

Treatment:

Device: Persona Revision Knee System

5) Revision Splined PS/CPS

Description:

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.

Treatment:

Device: Persona Revision Knee System

6) Revision Cemented PS/CPS

Description:

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.

Treatment:

Device: Persona Revision Knee System

7) Revision Cemented CCK with 5 Degree Primary Tibia

Description:

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.

Treatment:

Device: Persona Revision Knee System

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

Description:

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.

Treatment:

Device: Persona Revision Knee System

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

Description:

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.

Treatment:

Device: Persona Revision Knee System

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

Description:

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.

Treatment:

Device: Persona Revision Knee System

11) Infection Cases

Description:

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