Osteoarthrosis, Knee
Conditions
Brief summary
100 knees with primary osteoarthritis and scheduled for a total knee replacement (TKR) will be recruited from our waiting list. The patients will be randomized to become operated with the Attune or PFC total knee arthroplasty. Randomisation will be done using envelopes. Patients can only participate with one knee.
Detailed description
The Attune total knee replacement is a recently developed implant with the intention to improve the outcome after this procedure. One of the primary aims is to improve the kinematics of the knee in order to more closely mimic the normal knee. Thereby the patients are expected to experience improved function, better stability and less pain during activity. So far there are no randomized studies which have demonstrated this potential superior performance when compared to its predecessor, the PFC Sigma TKR. This study aims to evaluate the clinical outcome and the knee kinematics of the Attune knee using recognized clinical outcome parameters and dynamic radiostereometry. The PFC sigma knee will be used as control. 100 knees with primary osteoarthritis and scheduled for a total knee replacement (TKR) will be recruited from our waiting list. The patients will be randomized to become operated with the Attune or PFC total knee arthroplasty. Randomization will be done using envelopes. Patients can only participate with one knee. Surgical procedure: The operations will be done according to our routines without use of bloodless field. Local analgesia will be infiltrated periarticulary during the operation. Cemented fixation will be used in all cases. So-called fast-trackprinciples will be applied in both Groups. Patients will be followed for five years.
Interventions
PROCEDURETotal Knee Replacement (2 different design)
Patients will randomely receive either Attune or PFC Sigma TKR
Sponsors
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with degenerative knee disease randomely receive one of two types of total knee prostheses
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patients with degenerative joint disease of the knee on our waiting list for a total knee replacement will be asked to participate in this study Inclusion Criteria: * Medial or lateral primary osteoarthritis (OA) Ahlbäck Grade 2-4 * Varus or valgus deformity ≤15 degrees, extension defect ≤15 degrees * BMI \<35 * ASA 1-3. * Coming from independent living in own home * Written informed consent
Exclusion criteria
* Cortisone treatment during the last 6 months before operation * Neurological diseases with symptoms, stroke with sequel * Endocrine diseases with symptoms * OA secondary to trauma, infection, inflammatory disease or congenital and acquired deformities * BMI \>=35 * OA of the hip with symptoms. (Patients operated with total hip arthroplasty are accepted) * Ongoing infection * Unable or unwilling to participate in the follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Knee Score (OKS) | Preoperatively to 2 years | The Oxford Knee Score (OKS) is a 12-item patient-reported outcome measure (PROM) specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is short, reproducible, valid and sensitive to clinically important changes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction is reported on a visual analogue scale (VAS) 1-10 | Preoperatively to 2 years | Patient satisfaction is reported on a visual analogue scale (VAS) 1-10 |
| Knee Kinematics, (anterior-posterior translations and axial rotations) | 2 years | Dynamic radiostereometric analysis with detailed recordings of the threedimensional motions of the knee during a step-up |
| Pain (VAS) | Preoperatively to 2 years | Patient pain reported on Visual Analogue Scales(VAS) 1-10 |
Countries
Sweden
Contacts
Primary ContactJohan N Kärrholm, MD, PhD
Backup ContactThom Magnusson, MD
Outcome results
None listed