Clinical Research Directory

Persona Total Knee Arthroplasty Outcomes Study

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance.

Persona SoluTion PPS Femur PMCF

The goal of this study is to generate clinical evidence and evaluate the safety and performance of the Persona® SoluTion® PPS Femurs in the US market, with data supporting global regulatory submissions, including CE marking under EU MDR. The target population consists of adults undergoing knee arthroplasty with the Persona SoluTion femoral component paired with a Medial Congruent (MC) or Posterior Stabilized (PS) articulating surface in line with its current cleared Instructions for Use (IFU). The primary endpoint is the assessment of clinical performance and benefits by evaluating the average change in the KOOS JR score between pre-operative and 2-year post-operative follow-up.

Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty

Cemented vs Cementless Persona Keel RCT

The main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona Keel cementless and cemented knee.

Zimmer POLAR Persona - TKA (EMEA Study)

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona knee implants used in primary total knee arthroplasty. The assessment will include: 1. Implant survivorship based on removal of a study device. 2. Safety based on incidence and frequency of adverse events. 3. Clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.

Persona Ti-Nidium Post-Market Clinical Follow-up

The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.

Vaccination Against Herpes Zoster in Patients With Inflammatory Rheumatic Diseases

The purpose of HZ-REUMA study is explore vaccine response and protection against shingles (herpes zoster, HZ) after vaccination with two doses of Shingrix in immunosuppressed patients with inflammatory rheumatic diseases (IRD) compared to immunocompetent patients with IRD (controls). Hypothesis: The immunological disturbance as part of the rheumatic disease in combination with different immunomodulating treatments may impair vaccine response to non-live HZ vaccine (Shingrix) and thereby lead to an insufficient protection against infection. Primary objective (outcome) 1. The impact of modern anti-rheumatic treatments including synthetic disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate and different biological treatments (anti-TNF, anti IL6r, anti-IL12/23/17, anti-CD20, anti-BlyS, anti-INFERON treatment, or targeted DMARDs (JAK-inhibitors) on antibody response elicited by two doses of subunit vaccine against herpes zoster (HZ) administrated 1-2 months apart in patients with IRD. Secondary outcomes 2. The numbers and frequency of antigen specific CD4 2+ T cells expressing ≥2 or more activation markers (TNFalpha, INF-gama, interleukin-2 or CD40ligand) 3. Long-term immunogenicity of two doses of Shingrix in immunosuppressed patients with IRD measured 3 and 5 after vaccination 4. the tolerability of the vaccine, the impact on existing rheumatic disease, and possible association with onset of new autoimmune diseases 5. if vaccination against herpes zoster protects against infections in patients with inflammatory rheumatic diseases Study Population Adult patients (18 years and older) with a clinically diagnosed inflammatory rheumatic disease and regularly followed at Skåne University Hospital, section for rheumatology in Lund/Malmö, Sweden are eligible for the study and will be offered vaccination free of charge. Control group comprises adult individuals with known inflammatory rheumatic disease without immunosuppressive treatment except for low dose prednisone (max 5 mg daily) . Inclusion criteria: * age ≥18 years (patients) * regular follow up at Skåne University Hospital, section for rheumatology Lund/Malmö due to an inflammatory rheumatic disease (patients) * receive active treatment with disease modifying anti-rheumatic drugs (DMARDs) such conventional synthetic (cs), biologic (b) or targeted synthetic (ts) DMARDs or patients without active immunosuppressive treatment (controls) Exclusions criteria * age \<18 years (patients) * pregnancy (women of childbearing potential, WOCBP, are not excluded since all patients using DMARDs are advised to use a safe and effective contraceptive method) * allergy/intolerability of any component in the vaccine * active infection inclusive herpes zoster (shingles) * received Shingrix vaccine previously * ongoing treatment with any immunosuppressive drug for the other diseases Target enrolment/sample size: 240. Study start date: December, 17 2024- June 30, 2029