Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy

Total Knee Arthroplasty Clinical Trial

Official title:

Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03041857
• Other study ID #: MedactaGMKSphere
• Status: Completed
• Phase: N/A
• First received: March 4, 2016
• Last updated: September 28, 2017
• Start date: December 2013
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: Institute for Biomechanics, ETH Zürich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Tibiofemoral Kinematics
• Total Knee Arthroplasty

Intervention

Radiation:
• Observational use of fluoroscopy

Locations

Country	Name	City	State
Switzerland	Institute for Biomechanics, ETH Zurich	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
Dr. Renate List	Balgrist University Hospital, Kantonsspital Winterthur KSW

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	3 hours