R3 Acetabular Hip system in patients with degenerative joint disease.
- Conditions
- Degenerative joint disease.Musculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12608000234314
- Lead Sponsor
- Smith & Nephew
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 70
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety will be measured by assessing all adverse events experienced by patients implanted with the study device.The incidence of surgery-related and device-related events such as device revision, component failure, malfunction, migration, subluxation, dislocation, loosening, nerve damage, deep infection, deep vein thrombosis, pulmonary embolism, or bone breakage/fracture will be collected.[Subjects will be seen at the 6 months, 1 year, 2 year, 3 year and 5 years interval post surgery.]
- Secondary Outcome Measures
Name Time Method Effectiveness will be measured using the Harris Hip Score, a patient self assessment questionnaire, and radiographic assessment.[Subjects will be seen at the 6 months, 1 year, 2 year, 3 year and 5 years interval]