Total Knee Replacement With the Attune vs. the Press Fit Condylar (PFC) Sigma.

Osteoarthrosis, Knee Clinical Trial

— Att16SM  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03077958
• Other study ID #: Attune2016SM
• Status: Recruiting
• Phase: N/A
• First received: April 28, 2016
• Last updated: March 7, 2017
• Start date: February 18, 2017
• Est. completion date: December 2022

Study information

• Verified date: March 2017
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Johan N Kärrholm, MD, PhD
• Phone: +46313428247
• Email: nils.karrholm[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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-track"principles will be applied in both Groups.

Patients will be followed for five years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Osteoarthritis
• Osteoarthrosis, Knee

Intervention

Procedure:
• Total Knee Replacement (2 different design)
Patients will randomely receive either Attune or PFC Sigma TKR

Locations

Country	Name	City	State
Sweden	Department of Orthopaedics	Molndal	Västra Götaland

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Knee Kinematics, (anterior-posterior translations and axial rotations)	Dynamic radiostereometric analysis with detailed recordings of the threedimensional motions of the knee during a step-up	2 years
Secondary	Pain (VAS)	Patient pain reported on Visual Analogue Scales(VAS) 1-10	Preoperatively to 2 years