RSA Study of Persona TKA With CR vs MC Polyethylene

Region Skane

Status: Active, not recruiting

Conditions: Osteoarthritis, Knee

Treatments: Device: Medial Congruent Polyethylene (MC)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03494348

Persona RSA study_MT

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Cruciate Retaining Polyethylene (CR)

No Intervention group

Description:

This is the standard Polyethylene articular surface

Medial Congruent Polyethylene (MC)

Active Comparator group

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.

Treatment:

Device: Medial Congruent Polyethylene (MC)