Skip to main content
OpenTrials
Completed

NCT Number: NCT02358434

ATTUNE TM Video-fluoroscopy Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Biomechanics

Zurich, Canton of Zurich, 8093, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral TKA (ATTUNETM) due to osteoarthrosis (OA)
  • Body mass index (BMI) ≤ 33
  • Good clinical outcome, Knee injury and Osteoarthritis Outcome Score (KOOS) > 70
  • No or very low Visual Analog Scale for Pain (VAS) < 2
  • At least one year post-op
  • Standardized general health survey score (SF-12) within the normal range for people in their age group

Exclusion criteria

  • Actual significant problem on lower extremities
  • Misaligned TKA
  • Any other arthroplasty at the lower extremities
  • Patient incapable to understand and sign informed consent
  • Incapable of performing the motion tasks
  • Pregnancy

Treatment and study plan

Observational use of fluoroscopy

Radiation

Primary outcomes

  1. Relationship between the knee flexion angle and the medial and lateral anterior-posterior translation of the condyles

    Time frame: 3 hours

    The primary outcome of this pilot study is the relationship between the knee flexion angle and the medial and lateral anterior-posterior translation of the condyles during level walking, stair descent, standing up from a chair, sitting onto a chair and deep knee bend.

Sponsors and collaborators

Lead sponsor

Dr. Renate List

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 9, 2015
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.