None listed
Conditions
Brief summary
We propose to undertake a prospective clinical trial assessing qualities of the short stem cementless femoral prosthesis Nanos by Smith & Nephew Pty Ltd. We will undertake a 10 year follow up, which will consist of bone mineral density (“DEXA”) scanning, Roentgenstereometric Analysis (“RSA”), conventional radiographs and functional assessment. Functional analysis will be undertaken by using EuroQuol Group 5-Dimension Self-Report Questionnaire (“EQ5D”) and the Oxford hip score (“OHS”). Follow up time points will include the preoperative visit, the inpatient stay, 6 weeks, 3 months, 12 months and 2 years, 5 years and 10 years post surgery reviews.
Interventions
A "shorter than usual" femoral component is trialed which requires smaller cuts and therefore less bone loss during THR surgery. THR surgery takes about 2 hours to perform. This implant is inserted into the upper end of the thigh bone and is part of the artificial hip joint. It remains in the body, hopefully for life. However, according to world medical literature, current implants are generally expected to last about 20 years and patients requiring THR surgery are getting younger. Should there
A "shorter than usual" femoral component is trialed which requires smaller cuts and therefore less bone loss during THR surgery. THR surgery takes about 2 hours to perform. This implant is inserted into the upper end of the thigh bone and is part of the artificial hip joint. It remains in the body, hopefully for life. However, according to world medical literature, current implants are generally expected to last about 20 years and patients requiring THR surgery are getting younger. Should therefore revision surgery be needed then the bone stock preserving option of the shorter NANOS insert leaves the revision surgeon more options at the time of a second operation.
Sponsors
Smith & Nephew
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
6.1 Inclusion 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. 10. The individual does not have 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 not immunologically suppressed, or receiving steroids in excess of physiologic dose requirements. 11. The individual is skeletally mature. 12. The individual is not pregnant. 13. The individual is not a prisoner. 14. The individual has no plans to relocate to another geographic area before the completion of the study.
Exclusion criteria
6.2 Exclusion 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°.
Outcome results
None listed