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TerminatedNCT00715143Updated Aug 31, 2022

Post Approval Study: NOVATION Ceramic Articulation Hip System

An interventional study of Novation Ceramic in Total Hip Replacement (Non-inflammatory), sponsored by Exactech. Terminated at 5 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-08-31.

Sponsored by Exactech · Not applicable, Interventional, and Treatment

Why this study was terminated
Exactech withdrew the PMA associated with the study device due to low market utilization
Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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").

Read the 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.

02

Conditions studied

  • Total Hip Replacement (Non-inflammatory)

Keywords

  • hip
  • replacement
  • ceramic
  • orthopaedic
  • joint
  • degenerative
  • non-inflammatory
  • osteoarthritis
  • avascular necrosis
  • congenital hip dysplasia
  • traumatic arthritis
03

In context

Osteoarthritis

4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 126 is above the median of 70 across 3,474 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Exactech is the lead sponsor of 17 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
126 participants (actual)

Study arms

  • 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.

    Device: Novation Ceramic

Interventions

  • DeviceNovation Ceramic

    This treatment is the study device (which will be compared to a similar historic control device)

    Also known as: Novation

06

What researchers measure

Primary outcomes

  1. Radiographic evaluation of radiolucency

    Radiographic analysis

    Time frame: Immediately post operation, 6 weeks, 6 months, annually 1-5 years

  2. Survivorship of device components

    Device Survivorship

    Time frame: Immediately post operation, 6 weeks, 6 months, annually 1-5 years

  3. Harris Hip Score

    Physician assessed outcome

    Time frame: Immediately post operation, 6 weeks, 6 months, annually 1-5 years

07

Study locations

5 sites
  • Shrock Orthopedic Research
    Fort Lauderdale, Florida 33316, United States
  • Resurgens Orthopaedics
    Cumming, Georgia 30041, United States
  • Fallon Clinic
    Worcester, Massachusetts 01608, United States
  • Tulsa Bone & Joint Associates
    Tulsa, Oklahoma 74146, United States
  • Hampton Roads Orthopaedics & Sports Medicine
    Newport News, Virginia 23606, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00715143
Lead sponsor
Exactech
Responsible party
Sponsor
First posted
Jul 15, 2008
Start date
Jun 2008
Primary completion
Feb 22, 2021
Completion
Feb 22, 2021
Last update
Aug 31, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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