Post Approval Study: NOVATION Ceramic Articulation Hip System
Post Approval Study: NOVATION Ceramic Articulation Hip System A Multi-Center, Open-Label Study to Evaluate the Mid and Long-Term Safety and Effectiveness of the Exactech NOVATION Ceramic Articulation Hip System
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Shrock Orthopedic Research
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-
Georgia
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Cumming, Georgia, United States, 30041
- Resurgens Orthopaedics
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Massachusetts
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Worcester, Massachusetts, United States, 01608
- Fallon Clinic
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Oklahoma
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Tulsa, Oklahoma, United States, 74146
- Tulsa Bone & Joint Associates
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Virginia
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Newport News, Virginia, United States, 23606
- Hampton Roads Orthopaedics & Sports Medicine
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
- Patient does not meet any of the Exclusion Criteria.
- Patient agrees to participate and sign the Informed Consent Form.
Exclusion Criteria
- 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.
- 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).
- Patient has poor bone quality (e.g., osteoporosis) where, in the investigator's opinion, there is inadequate bone to support the implant(s).
- Patient has the presence of a previous prosthetic hip replacement device (any type, including THA, surface replacement arthroplasty, endoprosthesis, etc.) in the operative hip joint.
- Patient is known to have presence of a highly communicable disease or diseases that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.).
- Patient is a prisoner.
- Patient is obese where obesity is defined as a Body Mass Index (BMI) greater than 35. BMI = Weight (lbs.) ÷ Height (in.)2 x 703
- Patient has neuropathic joints.
- Patient has known allergies to the implant materials.
- Patient is unwilling or unable to comply with postoperative rehabilitation instructions and weight bearing limitations.
- Patient's life expectancy is < 5 years due to chronic diseases such as cancer, congestive heart failure, etc.
- Patient is unwilling or unable (e.g. cases of reduced mental capacity) to return for follow-up as specified by the study protocol over a ten (10) year post-operative follow-up period.
- Patient has reduced mental capability (permanent or temporary) that would prevent following pre-surgical and post-surgical instructions.
- Patient otherwise meets the study criteria but refuses to consent in writing to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
OTHER: All subjects will be receive the Novation Ceramic on Ceramic Articulating Hip System
All subjects will receive the Novation Ceramic on Ceramic Articulating Hip System.
|
This treatment is the study device (which will be compared to a similar historic control device)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiographic evaluation of radiolucency
Time Frame: Immediately post operation, 6 weeks, 6 months, annually 1-5 years
|
Radiographic analysis
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Immediately post operation, 6 weeks, 6 months, annually 1-5 years
|
|
Survivorship of device components
Time Frame: Immediately post operation, 6 weeks, 6 months, annually 1-5 years
|
Device Survivorship
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Immediately post operation, 6 weeks, 6 months, annually 1-5 years
|
|
Harris Hip Score
Time Frame: Immediately post operation, 6 weeks, 6 months, annually 1-5 years
|
Physician assessed outcome
|
Immediately post operation, 6 weeks, 6 months, annually 1-5 years
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- CR05-005
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