Prospective randomised clinical trial assessing the subsidence and rotation of the K2 and Apex modular cementless femoral stems following primary total hip replacement

Global Orthopaedic Technology0 sites260 target enrollmentNovember 24, 2009

Overview

No summary available.

Registry

who.int

Start Date

November 24, 2009

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Global Orthopaedic Technology

•Inclusion Criteria
•1\.The individual has signed a Patient Informed Consent, specific to this study, and approved by the Institutional Ethics Review Board.
•2\.The individual is between the ages of 21 and 75 years.
•3\.The individual clinically qualifies for total hip arthroplasty (THA) surgery based on physical examination and history.
•4\.The individual is diagnosed with a primary diagnosis of Non Inflammatory Degenerative Joint Disease (osteoarthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation or diastrophic variant).
•5\.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/substance abuse).
•6\.The individual is skeletally mature.

•Exclusion Criteria
•1\.The individual is classified as morbidly obese (\>40 Body Mass Index).
•2\.The individual has an active infection within the affected hip joint.
•3\.The individual has a diagnosed systemic disease that would affect the subject’s welfare or overall outcome of the study (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy), is immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
•4\.The individual is pregnant.
•5\.The individual is a prisoner.
•6\.The individual has plans to relocate to another geographic area before study completion.