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RSA Study of Persona TKA With CR vs MC Polyethylene

NCT03494348 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-11-29

No results posted yet for this study

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.

We plan also to do a 5 year follow-up of the patients with RSA and PROMS.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

Medial Congruent Polyethylene (MC)

One group receives the conventional CR surface and the other the new MC articular surface

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • Region Skane

    lead OTHER

Principal Investigators

  • Gunnar Flivik, MD PhD · Dept of Orthopedics, Skåne University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2020-10-30
Completion
2023-12-31
FDA Device
Yes

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03494348 on ClinicalTrials.gov