Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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-track"principles will be applied in both Groups.
Patients will be followed for five years.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Replacement (2 different design) | Procedure | Patients will randomely receive either Attune or PFC Sigma TKR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Knee Score (OKS) | 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. | Preoperatively to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction is reported on a visual analogue scale (VAS) 1-10 | Patient satisfaction is reported on a visual analogue scale (VAS) 1-10 | Preoperatively to 2 years |
| Knee Kinematics, (anterior-posterior translations and axial rotations) |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johan N Kärrholm, MD, PhD | Contact | +46313428247 | nils.karrholm@vgregion.se | |
| Thom Magnusson, MD | Contact | +46705403085 | thom.magnusson@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Johan Kärrholm, MD PhD Professor | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopaedics | Recruiting | Mölndal | Västra Götaland County | S-43180 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39986061 | Derived | Fandriks A, Zugner R, Shareghi B, Karrholm J, Tranberg R. Skin and cluster markers underestimate knee flexion during controlled motions. Evaluation of 12 patients with knee arthroplasty using radiosterometric analysis as reference. J Biomech. 2025 Mar;182:112591. doi: 10.1016/j.jbiomech.2025.112591. Epub 2025 Feb 17. |
Not provided
Not provided
Data will be shared with the sponsor (DePuy).
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Patients with degenerative knee disease randomely receive one of two types of total knee prostheses
Not provided
Not provided
Not provided
Not provided
Dynamic radiostereometric analysis with detailed recordings of the threedimensional motions of the knee during a step-up
| 2 years |
| Pain (VAS) | Patient pain reported on Visual Analogue Scales(VAS) 1-10 | Preoperatively to 2 years |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |