Total Knee Replacement With the Attune vs. the Press Fit Condylar (PFC) Sigma. (Att16SM)
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|ClinicalTrials.gov Identifier: NCT03077958|
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : March 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthrosis, Knee||Procedure: Total Knee Replacement (2 different design)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients with degenerative knee disease randomely receive one of two types of total knee prostheses|
|Masking:||None (Open Label)|
|Official Title:||Total Knee Replacement With the Attune vs. the Press Fit Condylar (PFC) Sigma. Randomised Study of 50 Attune and 50 PFC Sigma Total Knee Replacements (TKRs)|
|Actual Study Start Date :||February 18, 2017|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2022|
- Procedure: Total Knee Replacement (2 different design)
Patients will randomely receive either Attune or PFC Sigma TKROther Name: Attune or PFC Sigma TKR
- Oxford Knee Score (OKS) [ Time Frame: 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.
- Patient satisfaction is reported on a visual analogue scale (VAS) 1-10 [ Time Frame: Preoperatively to 2 years ]Patient satisfaction is reported on a visual analogue scale (VAS) 1-10
- Knee Kinematics, (anterior-posterior translations and axial rotations) [ Time Frame: 2 years ]Dynamic radiostereometric analysis with detailed recordings of the threedimensional motions of the knee during a step-up
- Pain (VAS) [ Time Frame: Preoperatively to 2 years ]Patient pain reported on Visual Analogue Scales(VAS) 1-10
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077958
|Contact: Johan N Kärrholm, MD, PhDfirstname.lastname@example.org|
|Contact: Thom Magnusson, MDemail@example.com|
|Department of Orthopaedics||Recruiting|
|Molndal, Västra Götaland, Sweden, S-43180|
|Contact: Johan N Kärrholm, MD +46313422847 firstname.lastname@example.org|
|Contact: Thom Magnusson, MD +46313430861 email@example.com|
|Principal Investigator:||Johan Kärrholm, MD PhD Professor||Sahlgrenska University Hospital, Sweden|