RSA Study of Persona TKA With CR vs MC Polyethylene

Region Skane60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Radiostereometry (RSA)

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 Outcomes

Computer Tomography (CT)

Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position

Time frame: Preoperatively and 3 months postoperatively

Conventional radiography

Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position

Time frame: Preoperatively and 3 months postoperatively

General health questionnaire

EuroQol (EQ-5D) -standardized instrument for use of general health outcome

Time frame: 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