Post-approval Study of the DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System

Study Overview
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Brief Summary
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This study is being conducted to gather medium and long-term information regarding the performance and safety of the commercially available DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System.

Detailed Description
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This two-phased study on hip arthroplasty consists of a clinical follow-up phase and a clinical outcomes phase. The DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System consists of: a modular ceramic bearing insert that secures to a titanium metal alloy DURALOC® Option Acetabular Shell via a taper locking mechanism; and a ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis device configuration.

Official Title
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DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System PMA Post-approval Study

Conditions
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Non-inflammatory Joint Disease, Osteoarthritis, Avascular Necrosis, Congenital Hip Dysplasia, Post-traumatic Arthritis

Intervention / Treatment
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* Device: Total hip replacement/arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skeletally mature Provide informed consent Sufficient acetabular and femoral bone stock to seat the prosthesis Willing and able to return for follow-up as specified by the study protocol Willing and able to complete the hip outcomes questionnaire and quality of life survey (SF12) Undergo hip replacement due to non-inflammatory joint disease, including osteoarthritis, avascular necrosis, congenital hip dysplasia or post-traumatic arthritis. Exclusion Criteria: Diagnosis of inflammatory arthritides such as rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus, erythematosis etc. Active infections that may spread to other systems such as osteomyelitis, pyogenic infection of the hip joint overt infection, etc. Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb which impedes evaluation. Poor bone quality (e.g. osteoporosis) such that there is concern about the ability of inadequate bone stock to support the implant. Morbid obesity Involvement in high levels of activity or participation in active sports Involvement in heavy manual labor employment Increased likelihood of falls due to concomitant illnesses or impairment Pregnancy, breast-feeding, a prisoner, mentally incompetent, a known alcohol or drug abuser Diagnosis of metabolic disorders or receiving systemic pharmacological treatments leading to progressive deterioration of solid bone support for the implant Known history of conditions that may interfere with the total hip arthroplasty survival or outcome (e.g. Paget's disease, Charcot's disease) Known presence of active metastatic or neoplastic disease Known allergic reactions to implant materials (e.g. ceramic, metal) Known history of tissue reactions to implant corrosion or implant wear debris Disabilities of other joints that impedes evaluation (e.g. knees, ankles) Known presence of highly communicable disease or diseases that may limit follow-up (e.g. immunocompromised conditions, hepatitis, active tuberculosis etc.) Previous prosthetic hip replacement device (any type including THA, surface replacement arthroplasty, endoprosthesis etc.)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Duraloc Option COC Hip<br> | Device: Total hip replacement/arthroplasty<br>* Hip replacement<br>* Other names: DURALOC® Option Ceramic-on-Ceramic Hip system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study subject SF-12 health survey |  | 1, 2 ,3, 4 and 5 years | 
| SF-12 Health survey and Subject Outcomes Questionnaire |  | 6, 7, 8, 9 and 10 years | 
| Hip Function (using Harris Hip Score) |  | 6 weeks, 6 months and 1, 2, 3, 4, and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total hip replacement, Total hip arthroplasty