None listed
Conditions
Brief summary
This study will investigate functional performance of the R3 Acetabular System, compared to a previous design, the Reflection System. Both systems are under approval by the Therapeutic Goods Administration, however the functional performance of the R3 Acetabular System compared to other systems has not yet been investigated.
Interventions
The R3 Acetabular System is designed with large ball heads providing increased range of motion and greater stability. This can significantly reduce the risk of hip dislocation, which is a crucial factor in the long term success of an implant. CoCr is an alloy of cobalt chrome with improved properties that make it suitable for use against ultra high molecular weight polyethylene surfaces in opposing friction couples.the length of the study is upto 5 years.
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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/DDH). 3.Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk. 4 The patient will be available for follow-up throughout the duration of the study.
Exclusion criteria
Subjects 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 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 or osteopenia) 5.Patient has inflammatory joint disease (e.g. rheumatoid arthritis) 6.Patient has known moderate to severe renal insufficiency. 6.Patient has a known or suspected metal sensitivity. 7.Patient is immunosuppressed with diseases such as AIDS or receiving high doses of corticosteroids. 8.Patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the study including mental illness, mental retardation, or drug, alcohol abuse. 9.Patient is severely overweight.
Outcome results
None listed