ATTUNE TM Video-fluoroscopy Study

Completed

• Conditions: Total Knee Arthroplasty

• Registration Number: NCT02358434
• Lead Sponsor: Dr. Renate List

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-06
• Study First Posted: 2015-02-09
• Study Start: 2015-07
• Primary Completion: 2016-03
• Study Completion: 2016-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Institute for Biomechanics; 🇨🇭 Zurich, Switzerland