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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
Sponsor:
Information provided by (Responsible Party):
Johan Karrholm, Sahlgrenska University Hospital, Sweden

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.

Condition or disease Intervention/treatment Phase
Osteoarthrosis, Knee Procedure: Total Knee Replacement (2 different design) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement


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


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Pain (VAS) [ Time Frame: Preoperatively to 2 years ]
    Patient pain reported on Visual Analogue Scales(VAS) 1-10



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Johan N Kärrholm, MD, PhD +46313428247 nils.karrholm@vgregion.se
Contact: Thom Magnusson, MD +46705403085 thom.magnusson@vgregion.se

Locations
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Sweden
Department of Orthopaedics Recruiting
Molndal, Västra Götaland, Sweden, S-43180
Contact: Johan N Kärrholm, MD    +46313422847    nils.karrholm@vgregion.se   
Contact: Thom Magnusson, MD    +46313430861    thom.magnusson@vgregion.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Johan Kärrholm, MD PhD Professor Sahlgrenska University Hospital, Sweden

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Responsible Party: Johan Karrholm, MD Professor in Orthopaedics, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03077958     History of Changes
Other Study ID Numbers: Attune2016SM
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be shared with the sponsor (DePuy).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases