Clinical trial NCT02337244: Zimmer POLAR Persona - TKA (EMEA Study)
Official title: Persona Outcomes Led Assessment Research in Total Knee Arthroplasty (POLAR - TKA)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Severe Knee Pain
Severe Knee Disability
Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Polyarthritis
Keywords: Osteoarthritis
Rheumatoid arthritis
Traumatic arthritis
Polyarthritis
Total knee arthroplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2015-01-13
Enrollment: 777
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System.

Brief summary: 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.

Detailed description: This is a prospective, multicenter, non-controlled study of the commercially available Persona knee implants. The study will require each site to obtain Ethics approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.

Study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 5 days to 6 weeks, 3 to 6 months, 1 year, 2, 3, 4, and 5 years after implantation. The hospital CHU Clermont-Ferrand, France with PI Prof. Boisgard will conduct additional 7 (voluntary) and 10 years (standard of care) follow-up visits.

Eligibility criteria: 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.

Primary outcomes:
measure: Kaplan-Meier Implant Survivorship
timeFrame: 5 years
Secondary outcomes:
measure: 'Knee injury and Osteoarthritis Outcome Score' (KOOS) subscale scores.
timeFrame: 5 years
measure: 'Forgotten Joint Score' (FJS-12)
timeFrame: 5 years
measure: Oxford Knee Score (OKS)
timeFrame: 5 years
measure: EuroQol (EQ)-5D-3L score and EQ 'Visual Analog Scale' (VAS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Orthopädisches Spital Speising
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Montpellier
country: France
facility: Centre Hospitalier régional Universitaire de Montpellier
city: Braunschweig
country: Germany
facility: HEH Braunschweig
city: Heidelberg
country: Germany
facility: Atos Klinik Heidelberg
city: Delft
country: Netherlands
facility: Stichting Research Orthopedie & Reinier de Graaf Groep
city: Sabadell
country: Spain
facility: Hospital Parc Tauli
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
city: Leeds
country: United Kingdom
facility: University of Leeds
state: Leeds/UK
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Harrogate
country: United Kingdom
facility: Harrogate and District NHS
city: Newcastle
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals
Study officials:
affiliation: Orthopädisches Spital Speising, Wien, Austria
name: Martin Dominkus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stichting Research Orthopedie & Reinier de Graaf Groep, Delf, Netherlands
name: Hendrik Verburg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harrogate and District NHS, Harrogate, England
name: Nicholas London, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Clermont-Ferrand, Clermont-Ferrand, France
name: Stéphane Boisgard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Lapeyronie, Montpellier
name: François Canovas, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Parc Tauli, Sabadell
name: Pere Torner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Golden Jubilee National Hospital, Clydebank
name: Jon Clarke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Freeman Hospital, Newcastle
name: David Deehan, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: HEH Braunschweig
name: Karl Dieter Heller, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Atos Klinik Heidelberg
name: Fritz Thorey, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Miguel Servet Zaragoza
name: Fernando Martinez Delgado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leeds
name: Hermant Pandit, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mathijssen NMC, Verburg H, London NJ, Landsiedl M, Dominkus M. Patient reported outcomes and implant survivorship after Total knee arthroplasty with the persona knee implant system: two year follow up. BMC Musculoskelet Disord. 2019 Mar 4;20(1):97. doi: 10.1186/s12891-019-2470-y.