Total Knee Arthroplasty Videofluoroscopy

Dr. Renate List

Status: Completed

Conditions: Total Knee Anthroplasty

Treatments: Radiation: Observational use of fluoroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT03033940

ATTUNE-SIGMA-2016

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

19 participants in 2 patient groups

ATTUNE TM subjects

Treatment:

Radiation: Observational use of fluoroscopy

PFC Sigma subjects

Treatment:

Radiation: Observational use of fluoroscopy