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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

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.

Condition or disease Intervention/treatment
Total Knee Arthroplasty Tibiofemoral Kinematics Radiation: Observational use of fluoroscopy

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy
Actual Study Start Date : December 2013
Actual Primary Completion Date : August 2017
Actual Study Completion Date : September 2017

Group/Cohort Intervention/treatment
GMK Sphere
Subjects with a unilateral Medacta GMK Sphere TKA
Radiation: Observational use of fluoroscopy
GMK PS
Subjects with a unilateral Medacta GMK Primary PS Fixed Bearing TKA
Radiation: Observational use of fluoroscopy
GMK UC
Subjects with a unilateral Medacta GMK Primary UC Fixed Bearing TKA
Radiation: Observational use of fluoroscopy



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   40 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

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): NCT03041857


Locations
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Switzerland
Institute for Biomechanics, ETH Zurich
Zurich, Switzerland, 8093
Sponsors and Collaborators
Dr. Renate List
Kantonsspital Winterthur KSW
Balgrist University Hospital
Investigators
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Principal Investigator: Renate List, Dr. Institute for Biomechanics, ETH Zurich
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Responsible Party: Dr. Renate List, Doctor of Sciences (Dr. sc. ETH), Institute for Biomechanics, ETH Zürich
ClinicalTrials.gov Identifier: NCT03041857    
Other Study ID Numbers: MedactaGMKSphere
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Renate List, Institute for Biomechanics, ETH Zürich:
Videofluoroscopy
GMK Sphere
GMK PS Fixed Bearing
GMK UC Mobile Bearing