RSA Study of Persona TKA With CR vs MC Polyethylene

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03494348
• Other study ID #: Persona RSA study_MT
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Device:
• Medial Congruent Polyethylene (MC)
One group receives the conventional CR surface and the other the new MC articular surface

Locations

Country	Name	City	State
Sweden	Department of Orthopedics, Skane University Hospital, Lund University	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Zimmer Biomet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Computer Tomography (CT)	Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position	Preoperatively and 3 months postoperatively
Secondary	Conventional radiography	Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position	Preoperatively and 3 months postoperatively
Secondary	General health questionnaire	EuroQol (EQ-5D) -standardized instrument for use of general health outcome	Preoperatively, 1, 2 and 5 years postoperatively
Secondary	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