None listed
Conditions
Brief summary
The aim of this clinical study is to determine the safety and effectiveness of the cemented Total Hip System (E2 stem/P2 cup). This will be done by collecting information and data on measured outcomes on the Total Hip System, using RSA method to provide early results on the implant. The intended use of this implant is for patients with degenerative joint disease who require a primary total hip replacement.
Interventions
The E2 stem is a cemented femoral device made of chrome-cobalt alloy. The stem has a double tapered geometry to aid the taper- slip theory of cement fixation.
The P2-cup is an all-polyethylene acetabular component intended for cemented fixation. The polyethylene cup is manufactured from highly cross-linked polyethylene that is manufactured by a 7.5Mrad irradiation cycle, melt annealing and subsequent ethylene oxide sterilisation. It is manufactured in sizes to accept 32mm and 36mm diameter femo
The E2 stem is a cemented femoral device made of chrome-cobalt alloy. The stem has a double tapered geometry to aid the taper- slip theory of cement fixation. The P2-cup is an all-polyethylene acetabular component intended for cemented fixation. The polyethylene cup is manufactured from highly cross-linked polyethylene that is manufactured by a 7.5Mrad irradiation cycle, melt annealing and subsequent ethylene oxide sterilisation. It is manufactured in sizes to accept 32mm and 36mm diameter femoral heads. Surgical procedure is unilateral. Approximate duration of the surgical procedure time is 70 minutes. Theatre time is 2 hours.
Sponsors
Joint Research Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1.Patient requires unilateral primary total hip arthroplasty due to non- inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/ developmental dysplasia of the hip (DDH) who are candidates for a Cemented Total Hip System as determined jointly by the surgeon and patient. 2.Male and non-pregnant female patients aged 18 to 75 3.Patients who understand the conditions of the study and are willing and able to give written informed consent to participate in the length of the study including prescribed follow-ups.
Exclusion criteria
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 postoperative 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 acquired immunodeficiency 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 Clinical Evaluation including mental illness, mental retardation, or drug, alcohol abuse. 10.Patient is severely overweight. Body Mass Index BMI > 40.
Outcome results
None listed