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Total Knee Arthroplasty Videofluoroscopy

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ClinicalTrials.gov Identifier: NCT03033940
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Renate List, Institute for Biomechanics, ETH Zürich

Tracking Information
First Submitted Date January 25, 2017
First Posted Date January 27, 2017
Last Update Posted Date December 20, 2019
Actual Study Start Date October 2016
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2017)
Comparison of the three-dimensional kinematics of the cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved CR Fixed Bearing TKA [ Time Frame: 3 hours ]
With video-fluoroscopic assessment it is possible to directly measure the kinematics of the tibial and the femoral components in vivo during daily activities, such as level walking, a deep knee bend (only ATTUNETM subjects), sitting down onto a chair, standing up from a chair and stair descent. Thus, for the first time the present study provides in vivo assessed data of the 3D motion of the ATTUNETM System during daily activities and allows a comparison to a conventional TKA based on the same methodology. The knowledge of the in vivo kinematic behaviour of the ATTUNETM System in comparison to the conventional TKA leads to an improved understanding of the design principle.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Total Knee Arthroplasty Videofluoroscopy
Official Title Kinematics Analysis: Comparison Between the Cruciate Retaining, Fixed Bearing Primary Total Knee Arthroplasty ATTUNE TM Knee System and the Fixed Bearing PFC Sigma Curved Total Knee Arthroplasty
Brief Summary

The primary objective is to quantify and compare the three-dimensional kinematics of the cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved CR Fixed Bearing TKA (both DePuy Synthes, Johnson and Johnson) during daily activities.

The secondary objective is to describe the kinematics in terms of range of motion, patterns of anterior-posterior motion of the nearest medial and lateral points ("posterior femoral rollback") and tibio-femoral internal/external rotation as well as the kinetics during daily activities, such as level gait, a deep knee bend (only ATTUNETM subjects), sitting down onto a chair, standing up from a chair and stair descent by means of video-fluoroscopy.

Furthermore, the encoded data will be handed over to DePuy Synthes (Johnson and Johnson) and to the Center for Orthopaedic Engineering of the University of Denver, where it will be used within a musculoskeletal model with the aim of simulating tibiofemoral contact mechanics and changes in the musculoskeletal system due to the TKA.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This is a prospective, observational study on 15 subjects with the ATTUNE TM CR Fixed Bearing TKA and 15 subjects with PFC Sigma Curved CR Fixed Bearing TKA during level walking, deep knee bend (only ATTUNE TM subjects), sitting down onto a chair, standing up from a chair and stair descent. The present study extends the subject groups of a previous feasibility study (KEK-ZH-Nr. 2014-0468) from 5 to 15 ATTUNE TM and from 6 to 15 PFC Sigma Curved CR Fixed Bearing TKA subjects. Based on a power analysis of the existing data of 5 ATTUNE TM subjects and 6 subjects with a PFC Sigma Curved CR Fixed Bearing TKA in the previous feasibility study (KEK-ZH-Nr. 2014-0468) the minimal sample size for the comparative evaluation of 15 subjects within each group was estimated. The participants must be able to perform the daily activity tasks mentioned above
Condition Total Knee Anthroplasty
Intervention Radiation: Observational use of fluoroscopy
Study Groups/Cohorts
  • ATTUNE TM subjects
    Intervention: Radiation: Observational use of fluoroscopy
  • PFC Sigma subjects
    Intervention: Radiation: Observational use of fluoroscopy
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 Completed
Actual Enrollment
 (submitted: January 25, 2017)
19
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2018
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Unilateral TKA (ATTUNETM/Sigma) due to osteoarthritis
  • BMI ≤ 33
  • Good clinical outcome, KOOS > 70
  • No or very low pain VAS < 2
  • At least one year post-op
  • Standardized general health survey score (SF-12) within the normal range for people in their age group

Exclusion Criteria:

  • Actual significant problem on lower extremities
  • Misaligned TKA
  • Any other arthroplasty at the lower extremities
  • Patient incapable to understand and sign informed consent
  • Incapable of performing the motion tasks
  • Pregnancy
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03033940
Other Study ID Numbers ATTUNE-SIGMA-2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Renate List, Institute for Biomechanics, ETH Zürich
Study Sponsor Dr. Renate List
Collaborators Not Provided
Investigators Not Provided
PRS Account Institute for Biomechanics, ETH Zürich
Verification Date December 2019