Osteoarthritis, Knee
Conditions
Keywords
Radiostereometry (RSA), Total Knee Arthroplasty
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.
Interventions
DEVICEMedial Congruent Polyethylene (MC)
One group receives the conventional CR surface and the other the new MC articular surface
Sponsors
Zimmer Biomet
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiostereometry (RSA) | First postoperative day, 3 months, 1 year, 2 years and 5 years | Measure the change in component migration over time (translation and rotation around the x-, y- and z-axis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Computer Tomography (CT) | Preoperatively and 3 months postoperatively | Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position |
| Conventional radiography | Preoperatively and 3 months postoperatively | Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position |
| General health questionnaire | Preoperatively, 1, 2 and 5 years postoperatively | EuroQol (EQ-5D) -standardized instrument for use of general health outcome |
| Knee specific health questionnaire | Preoperatively, 1, 2 and 5 years postoperatively | Knee disability and Osteoarthritis Outcome Score (KOOS) - this is a knee specific questionnaire measuring patients knee function and pain situation |
Countries
Sweden
Outcome results
None listed