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RSA Study of Persona TKA With CR vs MC Polyethylene

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494348
Recruitment Status : Active, not recruiting
First Posted : April 11, 2018
Last Update Posted : December 22, 2020
Sponsor:
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Region Skane

Study Description
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Brief Summary:
The aim of this study is to evaluate, over a 2 year period, the migration pattern, function and the possibility of anatomical reconstruction of a relatively new total knee arthroplasty (TKA) concept, the Persona. Sixty patients will be randomized into 2 groups of 30 patients each, with one group receiving the Persona TKA with a conventional Cruciate Retaining (CR) polyethylene articular surface and the other group with a newly developed Medial Congruent (MC) articular surface. Patients will be followed up with Radiostereometry (RSA), conventional radiography, outcome questionnaires, clinical evaluation and Computer Tomography (CT). The migration pattern of the components will be evaluated as well as the degree of anatomical reconstruction and clinical result.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Medial Congruent Polyethylene (MC) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Aspects of Alignment, Function, and Migration Behaviour in Two Conceptually Different Articular Surface Designs in the Cruciate Retaining Version of the Cemented Persona Knee System - A Randomized Study Evaluated by RSA and CT Analysis
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : October 30, 2020
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Cruciate Retaining Polyethylene (CR)
This is the standard Polyethylene articular surface
Active Comparator: Medial Congruent Polyethylene (MC)
The intervention here will be the MC articular surface. This is the new Polyethylene articular surface with a more congruent medial side and a more flat lateral side which should better resemble natural anatomy.
 Device: Medial Congruent Polyethylene (MC)
One group receives the conventional CR surface and the other the new MC articular surface
Other Name: MC


Outcome Measures
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Primary Outcome Measures :
  1. Radiostereometry (RSA) [ Time Frame: First postoperative day, 3 months, 1 year and 2 years ]
    Measure the change in component migration over time (translation and rotation around the x-, y- and z-axis)


Secondary Outcome Measures :
  1. Computer Tomography (CT) [ Time Frame: Preoperatively and 3 months postoperatively ]
    Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position

  2. Conventional radiography [ Time Frame: Preoperatively and 3 months postoperatively ]
    Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position

  3. General health questionnaire [ Time Frame: Preoperatively, 1 and 2 years postoperatively ]
    EuroQol (EQ-5D) -standardized instrument for use of general health outcome

  4. Knee specific health questionnaire [ Time Frame: Preoperatively, 1 and 2 years postoperatively ]
    Knee disability and Osteoarthritis Outcome Score (KOOS) - this is a knee specific questionnaire measuring patients knee function and pain situation


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Osteoarthritis of the knee necessitating knee replacement
  • ASA I-III
  • BMI 18 - 35

Exclusion Criteria:

  • Joint sepsis in history
  • immunosuppresive drugs last 5 years
  • Rheumatoid arthritis
  • Severe osteoporosis or other metabolic bone diseases
  • Neuromuscular diseases
  • Personal disorders suspected of limiting rehab and completion of the trial period
  • Previous osteotomy of affected limb
  • Intra-articular knee fracture of affected limb
  • Peroperative fracture
  • Severe deformity of affected joint in need of augmentation or excessive release
  • Obvious need for more constrained knee than CR
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494348


Locations
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Sweden
Department of Orthopedics, Skane University Hospital, Lund University
Lund, Sweden, 22185
Sponsors and Collaborators
Region Skane
Zimmer Biomet
Investigators
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Principal Investigator: Gunnar Flivik, MD PhD Dept of Orthopedics, Skåne University Hospital
More Information
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT03494348    
Other Study ID Numbers: Persona RSA study_MT
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Region Skane:
Radiostereometry (RSA)
Total Knee Arthroplasty
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases