ATTUNE TM Video-fluoroscopy Study

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358434
• Other study ID #: ATTUNE-2015
• Status: Completed
• Phase: N/A
• First received: February 4, 2015
• Last updated: January 25, 2017
• Start date: July 2015
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: Institute for Biomechanics, ETH Zürich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Radiation:
• Observational use of fluoroscopy

Locations

Country	Name	City	State
Switzerland	Institute for Biomechanics	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Renate List

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between the knee flexion angle and the medial and lateral anterior-posterior translation of the condyles	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.	3 hours