RSA Study of Persona TKA With CR vs MC Polyethylene

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Medial Congruent Polyethylene (MC)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 22185
    • Department of Orthopedics, Skåne University Hospital, Lund University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: MC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiostereometry (RSA)	Measure the change in component migration over time (translation and rotation around the x-, y- and z-axis)	First postoperative day, 3 months, 1 year, 2 years and 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Computer Tomography (CT)	Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position	Preoperatively and 3 months postoperatively
Conventional radiography	Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position	Preoperatively and 3 months postoperatively
General health questionnaire	EuroQol (EQ-5D) -standardized instrument for use of general health outcome	Preoperatively, 1, 2 and 5 years postoperatively
Knee specific health questionnaire	Knee disability and Osteoarthritis Outcome Score (KOOS) - this is a knee specific questionnaire measuring patients knee function and pain situation	Preoperatively, 1, 2 and 5 years postoperatively

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Zimmer Biomet
• Investigators: Principal Investigator: Gunnar Flivik, MD PhD, Dept of Orthopedics, Skåne University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): October 30, 2020
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Radiostereometry (RSA)
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Persona RSA study_MT

Drug and device information, study documents

• 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