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Post Approval Study: NOVATION Ceramic Articulation Hip System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00715143
Recruitment Status : Recruiting
First Posted : July 15, 2008
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Exactech

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"). 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.

Condition or disease Intervention/treatment Phase
Total Hip Replacement (Non-inflammatory) Device: Novation Ceramic Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : June 2008
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
N
This treatment arm includes ceramic-on-ceramic hip device
Device: Novation Ceramic
This treatment is the study device (which will be compared to a similar historic control device)
Other Name: Novation




Primary Outcome Measures :
  1. Radiographic evaluation of radiolucency [ Time Frame: Immediately post operation, 6 weeks, 6 months, annually 1-5 years ]
  2. Survivorship of device components [ Time Frame: Immediately post operation, 6 weeks, 6 months, annually 1-5 years ]
  3. Harris Hip Score [ Time Frame: Immediately post operation, 6 weeks, 6 months, annually 1-5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria

  1. Patient will be less than 21 years old at the time of surgery.
  2. Patient is skeletally immature.
  3. Patient presents with inflammatory degenerative joint disease.
  4. Patient has evidence of active infection, but not including asymptomatic urinary tract infection (UTI) if treated with antibiotics preoperatively.
  5. Patient is female and of child bearing age and is pregnant or whose pregnancy status is unknown.
  6. Patient has neurological or musculoskeletal disease that may adversely affect gait or weight bearing.
  7. 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).
  8. Patient has poor bone quality (e.g., osteoporosis) where, in the investigator's opinion, there is inadequate bone to support the implant(s).
  9. 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.
  10. 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.).
  11. Patient is a prisoner.
  12. Patient is obese where obesity is defined as a Body Mass Index (BMI) greater than 35. BMI = Weight (lbs.) ÷ Height (in.)2 x 703
  13. Patient has neuropathic joints.
  14. Patient has known allergies to the implant materials.
  15. Patient is unwilling or unable to comply with postoperative rehabilitation instructions and weight bearing limitations.
  16. Patient's life expectancy is < 5 years due to chronic diseases such as cancer, congestive heart failure, etc.
  17. 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.
  18. Patient has reduced mental capability (permanent or temporary) that would prevent following pre-surgical and post-surgical instructions.
  19. Patient otherwise meets the study criteria but refuses to consent in writing to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715143


Contacts
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Contact: Rena White 352-377-1140 rena.white@exac.com

Locations
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United States, Florida
Shrock Orthopedic Research Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Wendy Schwartz    954-626-3743    Wendy@shrockresearch.com   
Principal Investigator: Kevin Shrock, MD         
United States, Georgia
Resurgens Orthopaedics Recruiting
Cumming, Georgia, United States, 30041
Contact: Mary Jo Satusky, RN    678-341-6789    satuskymj@resurgens.com   
Principal Investigator: David Covall, MD         
United States, Massachusetts
Fallon Clinic Recruiting
Worcester, Massachusetts, United States, 01608
Contact: Peggy Preusse, RN    508-595-2219    Peggy.Preusse@reliantmedicalgroup.org   
Principal Investigator: William Balcom, MD         
United States, Oklahoma
Tulsa Bone & Joint Associates Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Tracee Thomas    918-392-1400    tracthomas@cox.net   
Principal Investigator: Scott Dunitz, MD         
United States, Virginia
Hampton Roads Orthopaedics & Sports Medicine Recruiting
Newport News, Virginia, United States, 23606
Contact: Mary Carter, RN    757-873-1554    mcarter@hrosm.com   
Principal Investigator: John Aldridge, MD         
Sponsors and Collaborators
Exactech
Investigators
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Study Director: Rena White Exactech

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Responsible Party: Exactech
ClinicalTrials.gov Identifier: NCT00715143    
Other Study ID Numbers: CR05-005
First Posted: July 15, 2008    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015
Keywords provided by Exactech:
hip
replacement
ceramic
orthopaedic
joint
degenerative
non-inflammatory
osteoarthritis
avascular necrosis
congenital hip dysplasia
traumatic arthritis