ACTRN12608000234314
Completed
Phase 4
A prospective, multicenter, non-randomized study to evaluate the safety and efectiveness of the R3 Acetabular Hip System in patients with degenerative joint disease.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Degenerative joint disease.
- Sponsor
- Smith & Nephew
- Enrollment
- 70
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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