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Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy

NCT ID: NCT03041857

Last Updated: 2017-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Total Knee Arthroplasty Tibiofemoral Kinematics

Keywords

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Videofluoroscopy GMK Sphere GMK PS Fixed Bearing GMK UC Mobile Bearing

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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GMK Sphere

Subjects with a unilateral Medacta GMK Sphere TKA

Observational use of fluoroscopy

Intervention Type RADIATION

GMK PS

Subjects with a unilateral Medacta GMK Primary PS Fixed Bearing TKA

Observational use of fluoroscopy

Intervention Type RADIATION

GMK UC

Subjects with a unilateral Medacta GMK Primary UC Fixed Bearing TKA

Observational use of fluoroscopy

Intervention Type RADIATION

Interventions

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Observational use of fluoroscopy

Intervention Type RADIATION

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kantonsspital Winterthur KSW

OTHER

Sponsor Role collaborator

Balgrist University Hospital

OTHER

Sponsor Role collaborator

Dr. Renate List

OTHER

Sponsor Role lead

Responsible Party

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Dr. Renate List

Doctor of Sciences (Dr. sc. ETH)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Renate List, Dr.

Role: PRINCIPAL_INVESTIGATOR

Institute for Biomechanics, ETH Zurich

Locations

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Institute for Biomechanics, ETH Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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MedactaGMKSphere

Identifier Type: -

Identifier Source: org_study_id