Osteoarthritis
Conditions
Brief summary
This is a prospective, non-randomized, consecutive series, multicenter clinical study that will include patients who will have total hip replacement with the R3 Acetabular System.
Detailed description
The study design was selected to assess the safety and effectiveness profile of the R3 Acetabular System in patients with degenerative joint disease requiring primary total hip replacement. A non¬-randomized, consecutive series of up to 158 patients will be enrolled, and a maximum of 8 sites will participate in the study. Each site is allowed to enroll up to 22 patients. When 158 patients are enrolled from all sites, enrollment will be stopped, regardless of the number contributed from each site. The clinical data from this study will be compared with a historical control. The study will include follow up through 5 years.
Interventions
None listed
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient is of legal age to consent and skeletally mature. * Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, and dysplasia/DDH) * 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. * The patient will be available for follow-up throughout the duration of the study.
Exclusion criteria
* Patient has active infection or sepsis (treated or untreated) * Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery. * Patient is pregnant or plans to become pregnant during the course of the study Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia) * Patient has inflammatory joint disease (e.g. rheumatoid arthritis) * Patient has known moderate to severe renal insufficiency. * Patient has a known or suspected metal sensitivity. * Patient is immunosuppressed or receiving high doses of corticosteroids. * Patient has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, or drug, alcohol abuse. * Patient has BMI \>40. * Patient is a prisoner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness will be measured using the Harris Hip Score (HHS), The HOOS self assessment questionnaire, and radiographic assessment. Radiographic measures consist of radiolucencies, component position changes, and bony changes. | 3 months, 1-5 years | The objective of this study is to establish the safety and effectiveness of the R3 Acetabular System in primary total hip replacement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Post Operative - 5 years | All perioperative and postoperative device-related and surgical adverse events will be recorded during this study. |
Countries
Canada, United States
Outcome results
None listed