None listed
Conditions
Brief summary
The primary objective of this study is to evaluate migration of the Hyperion uncemented femoral stem in primary total hip replacement using Radiostereometric Analysis (RSA). RSA will be performed at discharge, 6 months, 1 year, 2 years and 5 years following surgery
Interventions
The purpose of the clinical study is to determine the predicted long-term safety and effectiveness of the Hyperion uncemented stem using Radiostereometric Analysis (RSA) to yield early results in small number of patients.
RSA is engaged to provide information to assess implant migration and can be used for early trials of new implant designs, potentially reducing the number of revisions by identifying new prosthesis that fail.
The medical device will be implanted using standard surgical techniqu
The purpose of the clinical study is to determine the predicted long-term safety and effectiveness of the Hyperion uncemented stem using Radiostereometric Analysis (RSA) to yield early results in small number of patients. RSA is engaged to provide information to assess implant migration and can be used for early trials of new implant designs, potentially reducing the number of revisions by identifying new prosthesis that fail. The medical device will be implanted using standard surgical technique, depending on the investigator’s standard procedure. Instrumentation specific for the device will be used. This is the only intervention for the patient and the intervention generally is completed within two hours.
Sponsors
Australian Orthopaedic Fixation Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
Patients must meet all of the following characteristics for inclusion in the study. 1. Patient is of legal age to consent and skeletally mature. 2. Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, and dysplasia or developmental dysplasia of the hip (DDH)) who are candidates for an uncemented femoral stem as determined jointly by the surgeon and patient. 3. Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, haematological, etc., conditions that would pose excessive operative risk. 4. Patient who understands the conditions of the study and are willing and able to give written informed consent to participate in the length of the study and prescribed follow-ups.
Exclusion criteria
Patients with any of the following characteristics must be excluded from participation in the study. 1. Patient has active infection or sepsis (treated or untreated). 2. Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or post-operative recovery. 3. Patient is female of child-bearing age and not taking contraceptive precautions. 4. Patient has inadequate bone stock to support the device (e.g., severe osteopenia, family history of severe osteoporosis) 5. Patient has inflammatory joint disease (e.g., rheumatoid arthritis). 6. Patient has known moderate to severe renal insufficiency. 7. Patient has a known or suspected metal sensitivity. 8. Patient is immunosuppressed with diseases such as Aquired Immune Deficiency Syndrome (AIDS) or receiving high doses of corticosteroids. 9. Patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the study including mental illness, intellectual disability, or drug, alcohol abuse. 10. Patient is severely overweight. Body Mass Index ( BMI) > 40.
Outcome results
None listed