NCT02358434

ATTUNE TM Video-fluoroscopy Study

Kinematics Analysis: Cruciate Retaining, Fixed Bearing Primary Total Knee Arthroplasty With the ATTUNE TM Knee System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Dr. Renate List · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The proposed study is a retrospective, observational study. A group of 5 subjects with the AttuneTM cruciate retaining (CR) fixed bearing total knee arthroplasty (TKA) are analysed during level walking, a deep knee bend, sitting down onto a chair, standing up from a chair and stair descent at least 12 months post-operatively, in terms of 3D fluoroscopic assessed tibio-femoral TKA motion as well as simultaneous skin marker assessed whole leg motion and ground reaction forces. The obtained information helps the manufacturer (DePuy) to evaluate, bring to market and advance the implant. Furthermore the information will be integrated in a model, which will be developed at the Center for Orthopaedic Engineering, University of Denver. By means of this model, different conditions such as the use of an advanced prosthesis design can be simulated and tested. The objective of this study is in a first step to demonstrate the capability of data collection and analysis of level gait, deep knee bend, sitting down onto a chair, standing up from a chair and stair descent on a limited sample size of five subjects. Secondly to quantify and describe the three-dimensional kinematics for the cruciate retaining (CR), fixed bearing AttuneTM TKA during daily activities such as those mentioned.

Conditions

• Total Knee Arthroplasty

Interventions

Type	Name	Description
RADIATION	Observational use of fluoroscopy

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-03-01
• Completion: 2016-09-01
• First posted: 2015-02-09
• Last updated: 2017-01-26

Locations

1 site across 1 country: Switzerland