Evaluating the Persona Revision Knee System for knee surgeries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the performance, clinical benefits, and safety of the Persona Revision Knee System in patients who have undergone primary or revision total knee arthroplasty. It will utilize a multicenter, single-arm, consecutive series approach, retrospectively identifying eligible patients and inviting them for prospective follow-up at 1 to 5 years post-surgery. The primary endpoint will focus on improvements in knee function as measured by the Knee Society Clinical Rating System. A total of 20 sites will participate, with an enrollment cap of 380 patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Advanced Orthopaedic Specialists
  Fayetteville, Arkansas, United States Recruiting
• Bowen Hefley Orthopedics
  Little Rock, Arkansas, United States Recruiting
• Jeff Yergler, LLC
  Granger, Indiana, United States Recruiting
• Ascension Providence Rochester Hospital
  Rochester, Michigan, United States Recruiting
• Michigan Orthopaedic Surgeons, PLLC
  Southfield, Michigan, United States Recruiting
• Orthopaedic Research Institute of New Jersey
  Chester, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Chelsea Smith
• Email: chelsea.smith2@zimmerbiomet.com
• Phone: 714-740-9438

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparison of two knee implant designs for total knee replacement

  This study is testing which of two different knee implant designs helps people who have knee replacement surgery feel better and be more satisfied afterward.

  Recruiting LifeBridge Health · Baltimore, Maryland · NCT04814082

• Effects of virtual reality on walking in adults with knee osteoarthritis

  This study tests how immersive virtual reality environments—designed to feel safe or to provoke fear—affect walking and worry about movement in adults 50 and older with knee osteoarthritis and in healthy peers.

  Recruiting University of Primorska · Vilnius and 1 other locations · NCT07920120

• Weekly berobenatide for knee osteoarthritis in adults who are overweight or obese

  This study tests whether weekly berobenatide helps reduce knee pain and improve function, while also affecting body weight, in adults with knee osteoarthritis who are overweight or obese (with or without type 2 diabetes).

  Recruiting Phase 3 Pfizer · Birmingham, Alabama and 3 other locations · NCT07915609

• Autologous adipose-derived stem cell injections for knee osteoarthritis

  We’re testing whether injecting a patient’s own fat-derived stem cells into the knee can help people with knee OA feel less pain and move better, compared with a standard hyaluronic acid treatment.

  Recruiting at 3 sites Yonsei University · Incheon and 2 other locations · NCT07901790

• Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty

  This study tests whether higher burden of preoperative multimorbidity affects functional recovery after knee replacement in adults with knee osteoarthritis.

  Recruiting Balikesir Ataturk City Hospital · Balıkesir · NCT07882316

• Cartilage biomarker response to acute loading in knee OA by antiresorptive treatment status

  Researchers will test whether a 30-minute treadmill walk changes cartilage biomarkers in postmenopausal women with knee osteoarthritis, comparing those on denosumab, bisphosphonates, and those not on antiresorptives.

  Recruiting Sisli Hamidiye Etfal Training and Research Hospital · Istanbul, Istanbul · NCT07881861

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.