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

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: Total Hip Replacement (Non-inflammatory)
• Intervention / Treatment: Device: Novation Ceramic

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

Study Locations

• United States
  • 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

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

How is the study designed?

Design Details

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

Number of Arms

1

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.	Device: Novation Ceramic; 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	Radiographic analysis	Immediately post operation, 6 weeks, 6 months, annually 1-5 years
Survivorship of device components	Device Survivorship	Immediately post operation, 6 weeks, 6 months, annually 1-5 years
Harris Hip Score	Physician assessed outcome	Immediately post operation, 6 weeks, 6 months, annually 1-5 years

Collaborators and Investigators

• Sponsor: Exactech

Study record dates

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

• Keywords: osteoarthritis; ceramic; joint; hip; replacement; avascular necrosis; degenerative; traumatic arthritis; orthopaedic; non-inflammatory; congenital hip dysplasia
• Other Study ID Numbers: CR05-005