Avascular Necrosis, Congenital Hip Dysplasia, Non-inflammatory Joint Disease, Osteoarthritis, Post-traumatic Arthritis
Conditions
Keywords
Total hip replacement, Total hip arthroplasty
Brief summary
This study is being conducted to gather medium and long-term information regarding the performance and safety of the commercially available DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System.
Detailed description
This two-phased study on hip arthroplasty consists of a clinical follow-up phase and a clinical outcomes phase. The DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System consists of: 1. a modular ceramic bearing insert that secures to a titanium metal alloy DURALOC® Option Acetabular Shell via a taper locking mechanism; and 2. a ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis device configuration.
Interventions
DEVICETotal hip replacement/arthroplasty
Hip replacement
Sponsors
DePuy Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Skeletally mature * Provide informed consent * Sufficient acetabular and femoral bone stock to seat the prosthesis * Willing and able to return for follow-up as specified by the study protocol * Willing and able to complete the hip outcomes questionnaire and quality of life survey (SF12) * Undergo hip replacement due to non-inflammatory joint disease, including osteoarthritis, avascular necrosis, congenital hip dysplasia or post-traumatic arthritis.
Exclusion criteria
* Diagnosis of inflammatory arthritides such as rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus, erythematosis etc. * Active infections that may spread to other systems such as osteomyelitis, pyogenic infection of the hip joint overt infection, etc. * Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb which impedes evaluation. * Poor bone quality (e.g. osteoporosis) such that there is concern about the ability of inadequate bone stock to support the implant. * Morbid obesity * Involvement in high levels of activity or participation in active sports * Involvement in heavy manual labor employment * Increased likelihood of falls due to concomitant illnesses or impairment * Pregnancy, breast-feeding, a prisoner, mentally incompetent, a known alcohol or drug abuser * Diagnosis of metabolic disorders or receiving systemic pharmacological treatments leading to progressive deterioration of solid bone support for the implant * Known history of conditions that may interfere with the total hip arthroplasty survival or outcome (e.g. Paget's disease, Charcot's disease) * Known presence of active metastatic or neoplastic disease * Known allergic reactions to implant materials (e.g. ceramic, metal) * Known history of tissue reactions to implant corrosion or implant wear debris * Disabilities of other joints that impedes evaluation (e.g. knees, ankles) * Known presence of highly communicable disease or diseases that may limit follow-up (e.g. immunocompromised conditions, hepatitis, active tuberculosis etc.) * Previous prosthetic hip replacement device (any type including THA, surface replacement arthroplasty, endoprosthesis etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survivorship | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Study subject SF-12 health survey | 1, 2 ,3, 4 and 5 years |
| SF-12 Health survey and Subject Outcomes Questionnaire | 6, 7, 8, 9 and 10 years |
| Hip Function (using Harris Hip Score) | 6 weeks, 6 months and 1, 2, 3, 4, and 5 years |
Countries
United States
Outcome results
None listed