In patients with non-inflammatory joint disease who qualify for total hip replacement (THR) surgery, does insertion of the Nanos short stem femoral component enhance clinical outcomes?

Smith & Nephew0 sites25 target enrollmentJanuary 28, 2011

Overview

No summary available.

Registry

who.int

Start Date

January 28, 2011

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•6\.1Inclusion Criteria
•1\. The individual has signed a Patient Informed Consent (PIC”), specific to this study, and approved by the Institutional Ethics Review Board.
•2\. The individual is between the ages of 21 and 60 years.
•3\. The individual is not classified as obese.
•4\. The individual clinically qualifies for total hip arthroplasty surgery based on physical examination and medical history.
•5\. The individual is diagnosed with Non Inflammatory Degenerative Joint Disease (osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia).
•6\. The individual does not have an active infection within the affected hip joint.
•7\. The individual has not had a previous total hip replacement or hip fusion of the affected hip joint.
•8\. The individual is physically and mentally willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation (i.e., not currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, presence of alcohol or substance abuse).
•9\. The individual does not have a neuromuscular nor neurosensory deficiency, which limits the ability to evaluate the safety and effectiveness of the device.

•6\.2Exclusion Criteria
•1\. The individual has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and effectiveness of the device.
•2\. The individual has any type of radiologically detected osteopenia.
•3\. The individual has pronounced coxa valga with a femoral neck angle \> 145° or coxa vara with a femoral neck angle \< 125°.