Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy

• Sponsor: Medacta International SA (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02828293
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Duration (Months): 57
• Patients Per Site: 15
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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 and the GMK UC Fixed Bearing TKA.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty; Replacement, Knee	Other: Dynamic videofluoroscopic analysis

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy
• Study Start Date: Sep 1, 2014
• Anticipated Primary Completion Date: Jun 1, 2019
• Anticipated Study Completion Date: Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
GMK Sphere Patients who underwent total knee replacement using GMK Sphere implants. Patients underwent surgery before the inclusion in the study.	Other: Dynamic videofluoroscopic analysis; Patients bearing 3 different prosthesis (3 groups) will be prospactively assessed with videofluoroscopy.
GMK PS Fixed Bearing Patients who underwent total knee replacement using GMK PS Fixed Bearing implants. Patients underwent surgery before the inclusion in the study.	Other: Dynamic videofluoroscopic analysis; Patients bearing 3 different prosthesis (3 groups) will be prospactively assessed with videofluoroscopy.
GMK UC Fixed Bearing Patients who underwent total knee replacement using GMK UC Fixed Bearing implants. Patients underwent surgery before the inclusion in the study.	Other: Dynamic videofluoroscopic analysis; Patients bearing 3 different prosthesis (3 groups) will be prospactively assessed with videofluoroscopy.

Outcome Measures

Primary Outcome Measures

1. 2D/3D videofluoroscopy [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• subjects bearing a TKA with one of the studied prosthesis

• male and female older than 18 years old

• patients who are willing and able to sign an informed consent form

Exclusion Criteria:

• any case not described in the inclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Biomechanics ETH Zurich	Zurich		Switzerland	CH-8092
2	Institute for Biomechanics ETH Zurich	Zurich		Switzerland	CH-8092

Sponsors and Collaborators

• Medacta International SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medacta International SA
• ClinicalTrials.gov Identifier: NCT02828293
• Other Study ID Numbers: P02.014.11
• First Posted: Jul 11, 2016
• Last Update Posted: Mar 6, 2019
• Last Verified: Sep 1, 2017

Study Results

No Results Posted as of Mar 6, 2019