Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy

NCT03041857 | Completed

• 1 other identifier: MedactaGMKSphere
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty; Tibiofemoral Kinematics

Keywords

Videofluoroscopy; GMK Sphere; GMK PS Fixed Bearing; GMK UC Mobile Bearing

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (3)

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

Interventions

Observational use of fluoroscopy RADIATION

GMK PS; GMK Sphere; GMK UC

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dr. Renate List: lead
• Kantonsspital Winterthur KSW: collaborator
• Balgrist University Hospital: collaborator

Study Sites (1)

Institute for Biomechanics, ETH Zurich

Zurich, 8093, Switzerland

Location

Study Officials

• Renate List, Dr.

  Institute for Biomechanics, ETH Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Sciences (Dr. sc. ETH)

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: February 3, 2017
• Study Start: December 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 29, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)