ATTUNE TM Video-fluoroscopy Study

Dr. Renate List

Status: Completed

Conditions: Total Knee Arthroplasty

Treatments: Radiation: Observational use of fluoroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT02358434

ATTUNE-2015

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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