Post Approval Study: NOVATION Ceramic Articulation Hip System

August 26, 2022 updated by: Exactech

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

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").

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / 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:
  • Novation

What is the study measuring?

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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

February 22, 2021

Study Completion (ACTUAL)

February 22, 2021

Study Registration Dates

First Submitted

July 11, 2008

First Submitted That Met QC Criteria

July 14, 2008

First Posted (ESTIMATE)

July 15, 2008

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 26, 2022

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • CR05-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.