Rheumatoid Arthritis Clinical Trial
Official title:
Persona Outcomes Led Assessment Research in Total Knee Arthroplasty (POLAR - TKA)
Verified date | February 2023 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 777 |
Est. completion date | December 2027 |
Est. primary completion date | December 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patient 18-75 years of age, inclusive. - Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: - rheumatoid arthritis, osteoarthritis, traumatic arthritis, 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 that did not include partial or total knee arthroplasty of the ipsilateral knee. - Patient is willing and able to complete scheduled study procedures and follow-up evaluations. - Independent of study participation, patient is a candidate for commercially available Zimmer Persona knee implants implanted in accordance with product labeling. Exclusion Criteria: - Patient is currently participating in any other surgical intervention studies or pain management studies. - Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint. - Insufficient bone stock on femoral or tibial surfaces. - Skeletal immaturity. - Neuropathic arthropathy. - Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb. - Stable, painless arthrodesis in a satisfactory functional position. - Severe instability secondary to the absence of collateral ligament integrity. - Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin. - Patient has a known or suspected sensitivity or allergy to one or more of the implant materials. - Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.). - Patient has previously received partial or total knee arthroplasty for the ipsilateral knee. |
Country | Name | City | State |
---|---|---|---|
Austria | Orthopädisches Spital Speising | Wien | |
France | CHU de Clermont-Ferrand | Clermont-Ferrand | |
France | Centre Hospitalier régional Universitaire de Montpellier | Montpellier | |
Germany | HEH Braunschweig | Braunschweig | |
Germany | Atos Klinik Heidelberg | Heidelberg | |
Netherlands | Stichting Research Orthopedie & Reinier de Graaf Groep | Delft | |
Spain | Hospital Parc Tauli | Sabadell | |
Spain | Hospital Miguel Servet | Zaragoza | |
United Kingdom | Golden Jubilee National Hospital | Clydebank | |
United Kingdom | Harrogate and District NHS | Harrogate | |
United Kingdom | University of Leeds | Leeds | Leeds/UK |
United Kingdom | The Newcastle Upon Tyne Hospitals | Newcastle |
Lead Sponsor | Collaborator |
---|---|
Zimmer, GmbH |
Austria, France, Germany, Netherlands, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Kaplan-Meier Implant Survivorship | Kaplan-Meier survivorship at 5 years with revision of any implant component, for any reason, as endpoint. | 5 years | |
Secondary | 'Knee injury and Osteoarthritis Outcome Score' (KOOS) subscale scores. | The scores related to the five KOOS subscales calculated at different time points until 5 years. | 5 years | |
Secondary | 'Forgotten Joint Score' (FJS-12) | The score related to the FJS-12 patient-reported questionaire calculated at different time points until 5 years. | 5 years | |
Secondary | Oxford Knee Score (OKS) | The score related to the OKS patient-reported questionaire calculated at different time points until 5 years. | 5 years | |
Secondary | EuroQol (EQ)-5D-3L score and EQ 'Visual Analog Scale' (VAS) | The scores related to the EQ-5D-3L questionnaire and the EQ-VAS calculated at different time points until 5 years. | 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |