Persona Revision Knee System Outcomes

Conditions

• Arthroplasty Complications
• Infection
• Knee Disease
• Knee Osteoarthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Jun 14, 2021

Status verified

Dec 2024

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

380 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: 11) Infection Cases
  Any configuration of PRK components used for end stage (non-temporary) treatment

Primary Outcome Measure

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

Central Contacts

• Chelsea Smith
  714-740-9438
  [email protected]
• Charles Jaggard
  [email protected]

Locations (16)

Find similar trials in Fayetteville, AR

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