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RSA Study of Persona TKA With CR vs MC Polyethylene

Primary Purpose

Osteoarthritis, Knee

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Medial Congruent Polyethylene (MC)
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Radiostereometry (RSA), Total Knee Arthroplasty

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Orthopedics, Skane University Hospital, Lund University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Cruciate Retaining Polyethylene (CR)

Medial Congruent Polyethylene (MC)

Arm Description

This is the standard Polyethylene articular surface

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.

Outcomes

Primary Outcome Measures

Radiostereometry (RSA)
Measure the change in component migration over time (translation and rotation around the x-, y- and z-axis)

Secondary Outcome Measures

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

Full Information

First Posted
April 3, 2018
Last Updated
November 22, 2022
Sponsor
Region Skane
Collaborators
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT03494348
Brief Title
RSA Study of Persona TKA With CR vs MC Polyethylene
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
Collaborators
Zimmer Biomet

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Radiostereometry (RSA), Total Knee Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cruciate Retaining Polyethylene (CR)
Arm Type
No Intervention
Arm Description
This is the standard Polyethylene articular surface
Arm Title
Medial Congruent Polyethylene (MC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Medial Congruent Polyethylene (MC)
Other Intervention Name(s)
MC
Intervention Description
One group receives the conventional CR surface and the other the new MC articular surface
Primary Outcome Measure Information:
Title
Radiostereometry (RSA)
Description
Measure the change in component migration over time (translation and rotation around the x-, y- and z-axis)
Time Frame
First postoperative day, 3 months, 1 year, 2 years and 5 years
Secondary Outcome Measure Information:
Title
Computer Tomography (CT)
Description
Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position
Time Frame
Preoperatively and 3 months postoperatively
Title
Conventional radiography
Description
Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position
Time Frame
Preoperatively and 3 months postoperatively
Title
General health questionnaire
Description
EuroQol (EQ-5D) -standardized instrument for use of general health outcome
Time Frame
Preoperatively, 1, 2 and 5 years postoperatively
Title
Knee specific health questionnaire
Description
Knee disability and Osteoarthritis Outcome Score (KOOS) - this is a knee specific questionnaire measuring patients knee function and pain situation
Time Frame
Preoperatively, 1, 2 and 5 years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Flivik, MD PhD
Organizational Affiliation
Dept of Orthopedics, Skåne University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopedics, Skane University Hospital, Lund University
City
Lund
ZIP/Postal Code
22185
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

RSA Study of Persona TKA With CR vs MC Polyethylene

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