Total Hip Replacement (Non-inflammatory)
Conditions
Keywords
hip, replacement, ceramic, orthopaedic, joint, degenerative, non-inflammatory, osteoarthritis, avascular necrosis, congenital hip dysplasia, traumatic arthritis
Brief summary
The purpose of this study is to collect and evaluate long-term safety and effectiveness data on the Exactech® NOVATION ™ Ceramic Articulation Hip System (NOVATION ™ Ceramic AHS).
Detailed description
The purpose of this study is to collect and evaluate long-term safety and effectiveness data on the Exactech® NOVATION ™ Ceramic Articulation Hip System (NOVATION ™ Ceramic AHS). Ten (10) years of follow-up data will be collected in this study. The first five (5) years of subject follow-up will involve clinical (Harris Hip Score, adverse events), radiographic, and self-assessment evaluation. The remaining five (5) years of subject follow-up will be accomplished with an outcomes questionnaire that will be completed by the subjects to evaluate the survivorship status of their hip replacement.
Interventions
DEVICENovation Ceramic
This treatment is the study device (which will be compared to a similar historic control device)
Sponsors
Exactech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is undergoing primary hip surgery for symptomatic Non-inflammatory Degenerative Joint Disease (NIDJD). Composite diagnosis of NIDJD includes osteo/ degenerative arthritis, traumatic arthritis, congenital hip dysplasia and avascular necrosis. 2. Patient is 21 years of age or older at the time of surgery. 3. Patient is skeletally mature (tibial and femoral epiphyses are closed). 4. Patient is willing and able to return for follow-up as specified by the study protocol over a ten (10) year post-operative follow-up period; including 5 years of in-clinic visits followed by 5 years of mail-in questionnaire follow-up. 5. Patient is female and of childbearing age, for whom a negative urine pregnancy test is obtained immediately prior to surgery. 6. Patient does not meet any of the
Exclusion criteria
. 7. Patient agrees to participate and sign the Informed Consent Form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic evaluation of radiolucency | Immediately post operation, 6 weeks, 6 months, annually 1-5 years | Radiographic analysis |
| Survivorship of device components | Immediately post operation, 6 weeks, 6 months, annually 1-5 years | Device Survivorship |
| Harris Hip Score | Immediately post operation, 6 weeks, 6 months, annually 1-5 years | Physician assessed outcome |
Countries
United States
Outcome results
None listed