Status:
RECRUITING
Persona Revision Knee System Outcomes
Lead Sponsor:
Zimmer Biomet
Conditions:
Arthroplasty Complications
Infection
Eligibility:
All Genders
18+ years
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. Thi...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT04821154
Start Date
June 14 2021
End Date
December 31 2027
Last Update
October 24 2025
Active Locations (16)
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1
Advanced Orthopaedic Specialists
Fayetteville, Arkansas, United States, 72703
2
Bowen Hefley Orthopedics
Little Rock, Arkansas, United States, 72205
3
Community Foundation Medical Group
Fresno, California, United States, 93720
4
Cornerstone Orthopaedics & Sports Medicine
Superior, Colorado, United States, 80027