Total Knee Arthroplasty Videofluoroscopy

Completed

• Conditions: Total Knee Anthroplasty
• Interventions: Radiation: Observational use of fluoroscopy

• Registration Number: NCT03033940
• Lead Sponsor: Dr. Renate List

Brief Summary

The primary objective is to quantify and compare the three-dimensional kinematics of the cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved CR Fixed Bearing TKA (both DePuy Synthes, Johnson and Johnson) during daily activities.

The secondary objective is to describe the kinematics in terms of range of motion, patterns of anterior-posterior motion of the nearest medial and lateral points ("posterior femoral rollback") and tibio-femoral internal/external rotation as well as the kinetics during daily activities, such as level gait, a deep knee bend (only ATTUNETM subjects), sitting down onto a chair, standing up from a chair and stair descent by means of video-fluoroscopy.

Furthermore, the encoded data will be handed over to DePuy Synthes (Johnson and Johnson) and to the Center for Orthopaedic Engineering of the University of Denver, where it will be used within a musculoskeletal model with the aim of simulating tibiofemoral contact mechanics and changes in the musculoskeletal system due to the TKA.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-27
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-19
• Last Update Posted: 2019-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Unilateral TKA (ATTUNETM/Sigma) due to osteoarthritis
• BMI ≤ 33
• Good clinical outcome, KOOS > 70
• No or very low 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

Arm && Interventions

Group	Intervention	Description
ATTUNE TM subjects	Observational use of fluoroscopy	-
PFC Sigma subjects	Observational use of fluoroscopy	-

Primary Outcome Measures

Name	Time	Method
Comparison of the three-dimensional kinematics of the cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved CR Fixed Bearing TKA	3 hours	With video-fluoroscopic assessment it is possible to directly measure the kinematics of the tibial and the femoral components in vivo during daily activities, such as level walking, a deep knee bend (only ATTUNETM subjects), sitting down onto a chair, standing up from a chair and stair descent. Thus, for the first time the present study provides in vivo assessed data of the 3D motion of the ATTUNETM System during daily activities and allows a comparison to a conventional TKA based on the same methodology. The knowledge of the in vivo kinematic behaviour of the ATTUNETM System in comparison to the conventional TKA leads to an improved understanding of the design principle.

Trial Locations

Locations (1)

Institute for Biomechanics, ETH Zurich; 🇨🇭 Zurich, Switzerland