Post Approval Study: NOVATION Ceramic Articulation Hip System (NCT00715143) | Clinical Trial Compass
TerminatedNot Applicable
Post Approval Study: NOVATION Ceramic Articulation Hip System
Stopped: Exactech withdrew the PMA associated with the study device due to low market utilization
United States126 participantsStarted 2008-06
Plain-language 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").
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Patient is 21 years of age or older at the time of surgery.
✓. Patient is skeletally mature (tibial and femoral epiphyses are closed).
✓. 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.
✓. Patient is female and of childbearing age, for whom a negative urine pregnancy test is obtained immediately prior to surgery.
Exclusion criteria
✕. Patient agrees to participate and sign the Informed Consent Form.
✕. Patient will be less than 21 years old at the time of surgery.
✕. Patient is skeletally immature.
✕. Patient presents with inflammatory degenerative joint disease.
✕. Patient has evidence of active infection, but not including asymptomatic urinary tract infection (UTI) if treated with antibiotics preoperatively.
✕. Patient is female and of child bearing age and is pregnant or whose pregnancy status is unknown.
What they're measuring
1
Radiographic evaluation of radiolucency
Timeframe: Immediately post operation, 6 weeks, 6 months, annually 1-5 years
2
Survivorship of device components
Timeframe: Immediately post operation, 6 weeks, 6 months, annually 1-5 years
3
Harris Hip Score
Timeframe: Immediately post operation, 6 weeks, 6 months, annually 1-5 years
✕. Patient has neurological or musculoskeletal disease that may adversely affect gait or weight bearing.
✕. Patient has known presence of active metastatic or neoplastic disease (active is defined as within the past 5 years. Does not include basal cell carcinoma in cases when a subject with this diagnosis has undergone radical excision of the lesion, has pathological proof that the lesion has clean and clear peripheral and deep borders, and the location of the lesion is not near the operative hip or on the affected extremity).