Total Knee Replacement With the Attune vs. the Press Fit Condylar (PFC) Sigma. (Att16SM)

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)

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthrosis, Knee
• Intervention / Treatment: Procedure: Total Knee Replacement (2 different design)

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-track"principles will be applied in both Groups.

Patients will be followed for five years.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johan N Kärrholm, MD, PhD; Phone Number: +46313428247; Email: nils.karrholm@vgregion.se
• Study Contact Backup: Name: Thom Magnusson, MD; Phone Number: +46705403085; Email: thom.magnusson@vgregion.se

Study Locations

• Sweden
  • Västra Götaland
    • Molndal, Västra Götaland, Sweden, S-43180
      • Recruiting
      • Department of Orthopaedics
      • Contact: Johan N Kärrholm, MD; Phone Number: +46313422847; Email: nils.karrholm@vgregion.se
      • Contact: Thom Magnusson, MD; Phone Number: +46313430861; Email: thom.magnusson@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Johan Kärrholm, MD PhD Professor, Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: March 7, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: Attune2016SM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be shared with the sponsor (DePuy).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No