Post Approval Study: NOVATION Ceramic Articulation Hip System

NCT ID: NCT00715143

Last Updated: 2022-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2021-02-22

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").

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.

Conditions

Total Hip Replacement (Non-inflammatory)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Novation Ceramic

Intervention Type: DEVICE

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

Interventions

Novation Ceramic

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

Intervention Type: DEVICE

Other Intervention Names

Novation

Eligibility 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.

Exclusion Criteria

7. Patient agrees to participate and sign the Informed Consent Form.

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Exactech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shrock Orthopedic Research

Fort Lauderdale, Florida, United States

Resurgens Orthopaedics

Cumming, Georgia, United States

Fallon Clinic

Worcester, Massachusetts, United States

Tulsa Bone & Joint Associates

Tulsa, Oklahoma, United States

Hampton Roads Orthopaedics & Sports Medicine

Newport News, Virginia, United States

Countries

United States

Other Identifiers

CR05-005

Identifier Type: -

Identifier Source: org_study_id