Post Approval Study: NOVATION Ceramic Articulation Hip System

• Register: ClinicalTrials.gov
• Last refreshed on: 7 January 2013
• Main ID: NCT00715143
• Date of registration: 11/07/2008
• Primary sponsor: Exactech
• Public title: Post Approval Study: NOVATION Ceramic Articulation Hip System
• Scientific 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
• Date of first enrolment: June 2008
• Target sample size: 125
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00715143
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Rena White

• Name: Matthew Christensen, CCRA
• Affiliation: Exactech, Inc.

Key inclusion & exclusion 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.



Age minimum: 21 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Total Hip Replacement (Non-inflammatory)

Intervention(s)

Device: Novation Ceramic

Primary Outcome(s)

Harris Hip Score [Time Frame: Immediately post operation, 6 weeks, 6 months, annually 1-5 years]

Radiographic evaluation of radiolucency [Time Frame: 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]

Secondary ID(s)

CR05-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors