Viewing Study NCT02071745



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Study NCT ID: NCT02071745
Status: COMPLETED
Last Update Posted: 2014-02-26
First Post: 2014-02-18

Brief Title: Navigated Total Knee Arthroplasty the Correlation to CT Scans and Clinical Results
Sponsor: Ziv Hospital
Organization: Ziv Hospital

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2014-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Total knee replacement is one of the most commonly performed orthopedic procedures As of 2010 about 600000 total knee replacements were being performed annually in the United States and these numbers are rising The normal knee joint functions as a complex hinge allowing primarily flexion and extension rotation and gliding The knee joint is made up of three compartments the lateral medial and anterior patellofemoral Damage to the cartilage of one or more compartments may be the result of osteoarthritis idiopathic or post-traumatic inflammatory arthritis rheumatoidpsoriatic etc a-vascular necrosis tumors or congenital deformities Osteoarthritis and rheumatoid arthritis are the causes of the overwhelming majority of total joint arthroplasties

A successful Total knee arthroplastyTKA surgery includes an accurate alignment the mechanical axis in axial and rotational planes as well as significant pain relief which improves function and quality of life Incorrect alignment can lead to abnormal wear premature mechanical loosening of the components and patellofemoral problems

The common techniques for Total knee replacement are

1 Conventional method TKR
2 CTMRI-based preoperative navigated TKR
3 Image-free intraoperative navigated TKR In our research we focus on the 3rd method using the Orthopilot navigation system Aesculap Tutlingen Germany This system is an active PC based guiding system that helps the surgeon decide on the accurate alignment and orientation of the implant and cutting surfaces of the bone and thus avoid incorrect alignment

We aim to compare between pre-operative and post-operative lower limb alignment mechanical axis in Aesculap based TKA using serview CT Furthermore we will try to examine the existence of a correlation between the CT scans and the Orthopilot navigation system output and assess the clinical outcome of the patient postoperatively

Our Hypothesis is that the intra-operative navigation system is accurate and correlated to CT images results moreover allows the surgeon to achieve a good mechanical axis and high clinical outcome
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None