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ATTUNE TM Video-fluoroscopy Study

NCT02358434 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5

Last updated 2017-01-26

No results posted yet for this study

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

RADIATION

Observational use of fluoroscopy

Sponsors & Collaborators

  • Dr. Renate List

    lead OTHER

Principal Investigators

  • Renate List, PhD · ETH Zurich

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-03-31
Completion
2016-09-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02358434 on ClinicalTrials.gov