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NCT04821154 | RECRUITING | Arthroplasty Complications

Persona Revision Knee System Outcomes
Sponsor:

Zimmer Biomet

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.

Condition or disease

Arthroplasty Complications

Infection

Knee Disease

Knee Osteoarthritis

Intervention/treatment

Persona Revision Knee System

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 380 participants
Official Title : Clinical Investigation to Demonstrate Performance, Safety and Clinical Benefits of the Persona Revision Knee System
Actual Study Start Date : 2021-06-14
Estimated Primary Completion Date : 2027-12-31
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Persona Revision Knee System Outcomes

Location Details

NCT04821154

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arkansas

Advanced Orthopaedic Specialists

Fayetteville, arkansas, United States, 72703

RECRUITING

United States, Arkansas

Bowen Hefley Orthopedics

Little Rock, arkansas, United States, 72205

COMPLETED

United States, California

Community Foundation Medical Group

Fresno, California, United States, 93720

COMPLETED

United States, Colorado

Cornerstone Orthopaedics & Sports Medicine

Superior, Colorado, United States, 80027

RECRUITING

United States, Indiana

Orthopaedic Associates, Inc.

Evansville, Indiana, United States, 47710

RECRUITING

United States, Indiana

Jeff Yergler, LLC

Granger, Indiana, United States, 46530

RECRUITING

United States, Kentucky

Arthroplasty Foundation Inc.

Louisville, Kentucky, United States, 40220

RECRUITING

United States, Michigan

Ascension Providence Rochester Hospital

Rochester, Michigan, United States, 48307

ACTIVE NOT RECRUITING

United States, Michigan

Michigan Orthopaedic Surgeons, PLLC

Southfield, Michigan, United States, 48076

COMPLETED

United States, Minnesota

TRIA Orthopaedic Center Research Institute

Bloomington, Minnesota, United States, 55431

RECRUITING

United States, Missouri

Thomas Aleto MD, PC

Columbia, Missouri, United States, 65201

RECRUITING

United States, New Jersey

Orthopaedic Research Institute of New Jersey

Chester, New Jersey, United States, 07390

RECRUITING

United States, Ohio

The Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

RECRUITING

United States, Oregon

ROC Orthopedics

Oregon City, Oregon, United States, 97045

ACTIVE NOT RECRUITING

United States, Pennsylvania

Penn Medicine/ Lancaster General Health

Lancaster, Pennsylvania, United States, 17602

RECRUITING

United States, Wisconsin

Ortopedic Surgeons of Wisconsin, SC

They escaped, Wisconsin, United States, 53222