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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

Tracking Information
First Submitted Date  ICMJE April 28, 2016
First Posted Date  ICMJE March 13, 2017
Last Update Posted Date March 13, 2017
Actual Study Start Date  ICMJE February 18, 2017
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Total Knee Replacement With the Attune vs. the Press Fit Condylar (PFC) Sigma.
Official Title  ICMJE 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)
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Osteoarthrosis, Knee
Intervention  ICMJE Procedure: Total Knee Replacement (2 different design)
Patients will randomely receive either Attune or PFC Sigma TKR
Other Name: Attune or PFC Sigma TKR
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 7, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Johan N Kärrholm, MD, PhD +46313428247 nils.karrholm@vgregion.se
Contact: Thom Magnusson, MD +46705403085 thom.magnusson@vgregion.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03077958
Other Study ID Numbers  ICMJE Attune2016SM
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Data will be shared with the sponsor (DePuy).
Responsible Party Johan Karrholm, Sahlgrenska University Hospital, Sweden
Study Sponsor  ICMJE Sahlgrenska University Hospital, Sweden
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Johan Kärrholm, MD PhD Professor Sahlgrenska University Hospital, Sweden
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP