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Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy

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ClinicalTrials.gov Identifier: NCT03041857
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : September 29, 2017
Sponsor:
Collaborators:
Kantonsspital Winterthur KSW
Balgrist University Hospital
Information provided by (Responsible Party):
Dr. Renate List, Institute for Biomechanics, ETH Zürich

Tracking Information
First Submitted Date March 4, 2016
First Posted Date February 3, 2017
Last Update Posted Date September 29, 2017
Actual Study Start Date December 2013
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2017)
Comparison of the three-dimensional kinematics of the GMK Sphere Fixed Bearing TKA to the kinematics of the GMK Primary PS fixed bearing and GMK Primary UC Mobile 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, downhill walking and stair descent. Thus, for the first time the present study provides in vivo assessed data of the 3D motion of the GMK Sphere System during daily activities. The knowledge of the in vivo kinematic behaviour of the GMK Sphere System compared to conventional GMK PS Fixed Bearing and GMK UC Mobile Bearing TKA leads to an improved understanding of the design principle. Observation of the kinematics in terms of range of motion, patterns of anterior-posterior motion of medial and lateral condyle points ("posterior femoral rollback") and tibio-femoral internal/external rotation.
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 Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy
Official Title Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy
Brief Summary The objective of this research project is to perform a comparative study on the in vivo kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed Bearing TKA as well as to the GMK UC Mobile Bearing during level walking, stair descent and downhill walking by means of videofluoroscopy.
Detailed Description

Total arthroplasty of the knee (TKA) aims to relieve patient pain and improve functionality of the joint. To maintain sufficient range of motion, but also not overload the surrounding soft tissue structures, reproduction of tibio-femoral kinematics of the healthy knee is thought to be beneficial. In previous studies, it has been shown that the medial condyle, described by the centre of the medial condylar sphere, does not move anterioposteriorly during progressing joint flexion, whereas the lateral condyle has been observed to translate in a posterior direction producing tibial internal rotation with flexion (Freeman and Pinskerova 2003, Pinskerova, Johal et al. 2004, Freeman and Pinskerova 2005). The GMK Sphere prosthesis is specifically designed to mimic the healthy kinematics with providing a medial pivot.

The objective of this research project is to perform a comparative study on the in vivo kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed Bearing TKA as well as to the GMK UC Fixed Bearing. The study includes the simultaneous assessment of the 3D kinematics of the TKA by means of an automated moving fluoroscope and subsequent 2D/3D registration based on CAD models of the TKA, whole leg kinematics by means of skin markers and ground reaction forces during level walking, stair descent and downhill walking a 10° inclined slope. Precisely, the aim is to assess tibio-femoral kinematics in 8-10 TKA subjects implanted one or more years previously with the GMK Sphere prosthesis. In addition, 8-10 conventional GMK PS Fixed Bearing TKA subjects, as well as 8-10 GMK UC Mobile Bearing TKA subjects will be measured to provide a comparison against the GMK Sphere prosthesis kinematics.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants fulfilling all of the following inclusion criteria are eligible for the study. The presence of any one of the following exclusion criteria will lead to the exclusion of the participant.
Condition
  • Total Knee Arthroplasty
  • Tibiofemoral Kinematics
Intervention Radiation: Observational use of fluoroscopy
Study Groups/Cohorts
  • GMK Sphere
    Subjects with a unilateral Medacta GMK Sphere TKA
    Intervention: Radiation: Observational use of fluoroscopy
  • GMK PS
    Subjects with a unilateral Medacta GMK Primary PS Fixed Bearing TKA
    Intervention: Radiation: Observational use of fluoroscopy
  • GMK UC
    Subjects with a unilateral Medacta GMK Primary UC Fixed Bearing TKA
    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: February 1, 2017)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Female or male
  • Age: 40 to 100 years
  • Unilateral TKA
  • ≥ 1 years postoperatively
  • BMI ≤ 33
  • Good outcome, WOMAC between 0 to 28 (0-14 (Excellent), 15-28 (Good)) No pain subjects, VAS ≤ 2
  • Good health condition, adequate for test procedure

Exclusion Criteria:

  • Other actual significant problem on lower extremities
  • Any other arthroplasty at the lower extremities
  • Subject incapable to understand and sign informed consent
  • Pregnancy at time of testing
  • Incapable of performing the motion tasks
  • Misaligned TKA (≥ ± 3° from mechanical axis)
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03041857
Other Study ID Numbers MedactaGMKSphere
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr. Renate List, Institute for Biomechanics, ETH Zürich
Study Sponsor Dr. Renate List
Collaborators
  • Kantonsspital Winterthur KSW
  • Balgrist University Hospital
Investigators
Principal Investigator: Renate List, Dr. Institute for Biomechanics, ETH Zurich
PRS Account Institute for Biomechanics, ETH Zürich
Verification Date September 2017