Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty

Study Overview
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Brief Summary
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This is a multi-center, prospective, non-controlled post market surveillance study. The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.

Detailed Description
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The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and performance of the Allofit IT Ceramic Bearing System. A total of 200 patients will be enrolled in this study that will last 12 years (2 year enrollment plus 10 years follow-up) with the following visits at 6 months, 1, 2, 3, 5, 7, and 10 years post-operatively.

Official Title
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Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty: A Multi-center, Prospective, Non-controlled Post Market Surveillance Study

Conditions
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Avascular Necrosis of Hip, Osteoarthritis, Hip, Inflammatory Arthritis, Post-Traumatic Osteoarthritis of Hip

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 18 to 75 years of age, inclusive. Patient is skeletally mature. Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including the following: Avascular necrosis (AVN) Osteoarthritis (OA) Inflammatory arthritis (i.e. Rheumatoid arthritis) Post-traumatic arthritis Patient has no history of previous prosthetic replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) of the affected hip joint(s). Patient has a Harris Hip Score <70 in the affected hip Patient is willing and able to provide written informed consent. Patient is willing and able to cooperate in the required post-operative therapy. Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent. Patient has participated in the Informed Consent process and has signed the Ethics Committee approved informed consent. Exclusion Criteria: The patient is: A prisoner Mentally incompetent or unable to understand what participation in the study entails A known alcohol or drug abuser Anticipated to be non-compliant. The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care. The patient has a vascular (large and small vessel disease) insufficiency. The patient has a neurologic condition in the ipsalateral or contralateral limb which affects lower limb function. The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome. The patient is known to be pregnant. The patient is unwilling or unable to give informed consent, or to comply with the follow-up program. The patient has received an investigational drug or device within the previous 6 months. The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously. The patient has insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be used to assess the presence of adequate bone stock. The patient has osteoradionecrosis in the operative hip joint The patient has a known sensitivity or allergic reaction to one or more of the implanted materials. The patient has known local bone tumors in the operative hip. The patient is Grade III obese with a Body Mass Index (BMI) > 40.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who received the Allofit IT with BIOLOX delta<br>Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method |  | 10 years post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score is a SINGLE form to measure the functional outcome of the patient. | The Harris Hip Score is a questionnaire filled by the surgeon with the patient who received a hip implant. The domains covered are: pain (44 points), function (47 points), range of motion (5 points), and absence of deformity (4 points). Patients select a discrete set of answers which correspond to predefined point allocations based on the category. To obtain a final score, these values are summed. The scale then ranges as Excellent: 90 - 100, Good: 80 - 89, Fair: 70 - 79, Poor: < 70. | 10 years post-surgery | 
| EQ-5D is a SINGLE form to measure the quality-of-life of the patient. | The EQ-5D measures 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with a total of 5 questions. | 10 years post-surgery | 
| Subject quality-of-life determined by the SF-12 score | The SF-12 is a 12-item questionnaire in accordance with the quality of life questioning standards of the American Academy of Orthopaedic Surgeons (AAOS) Committee for Outcomes Research. The questions determine the patient's physical, emotional and social health and will be used to calculate a physical and mental functional score. This form is completed by the patient. | 10 years post-surgery | 
| X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc |  | 10 years post-surgery | 
| Safety based on eventual complications occurred including dislocations and revisions/removals |  | 10 years post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total hip arthroplasty, Medical Device, Safety, Hip prosthesis