Ceramic on Metal Total Hip Replacement System Multi-Center,Investigational Device Exemption Clinical Trial

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate non-inferiority of the Ceramic on Metal Total Hip when compared to a TRANSCEND® historical control group of patients with primary total hip replacement.

Detailed Description
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This investigational device study is a non-randomized, non-inferiority, multi-center, historically controlled study. The primary objective will be evaluated at the primary endpoint (24 months) by the primary efficacy and safety measures that define patient success. The proportion of patient success will determine whether the primary objective has been met (study success). The investigational device will be compared to a historical control comprised of patients from the TRANSCEND® Ceramic on Ceramic IDE study. This comparison will be made using all primary and secondary measures. However, only primary measures will be used to determine study success.

Official Title
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Ceramic on Metal Total Hip Replacement System IDE: A Non-Randomized, Multi-center, Historically Controlled Safety and Efficacy Study (Protocol Number:06-LJH-002)

Conditions
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Total Hip Replacement System

Intervention / Treatment
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* Device: Ceramic on metal prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be 18 years of age or older at the time of enrollment, Patient is skeletally mature, Evidence of a signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study, Patient agrees to comply with this protocol, including participating in required follow-up visits at the investigational site and completing study questionnaires, (i.e. patient's reasonable driving distance to assure study follow-up and completion) Investigator determines patient is a suitable candidate for primary total hip replacement, Body Mass Index (BMI) of <40, Preoperative Harris Hip Score (HHS) < 70 points as calculated on the Pre-screening Qualification Form and verified by the Sponsor, Have a diagnosis of degenerative joint disease of the hip. Exclusion Criteria: Previous total hip replacement, hemi-arthroplasty, or fusion on the ipsilateral side, Patients with a previous Girdlestone procedure, Patient has a known metal allergy to any component of the investigational device (e.g.cobalt, chromium, titanium or ceramics), Patient has had a total knee arthroplasty of either leg, Patient has vascular insufficiency, muscular atrophy, or neuromuscular disease in the affected limb (based on the Investigator's discretion), Patients with congenital disorder or deformity not adequately addressed by hip replacement or has sufficient anatomic variance or remodeling of the hip joint that may place the patient at risk for mechanical failure or that requires a structural bone graft (based on the Investigator's discretion), Patients with severe instability or deformity of the ligaments or surrounding soft tissues that would preclude stability of the implant (based on the Investigator's discretion), Patients with Charcot or neuropathic arthropathy, or neuromuscular disease or any other condition that would interfere with patient self-assessment or pain, the function or quality of life required for patient reported outcomes during the study (based on the Investigator's discretion), Patient, male or postmenopausal female, with a history of metabolic bone disease, as defined by the following: Osteoporosis where the patient is currently taking prescription medications that increase bone-mineral density (e.g. Fosamax, Didronel), or Patient was previously diagnosed with a metabolic bone disease (e.g. Paget's disease or osteomalacia), or Patient has any other metabolic bone disease to a degree that the investigator determines that a THR would be contraindicated, Active malignancy, Patient has an active infection (e.g. hepatitis, AIDS, ARC or is HIV positive)- systemic or at the site of intended surgery, Clinical diagnosis of renal insufficiency where renal function is abnormal and incapable of sustaining essential bodily functions. (e.g. as reported by KRONOS lab BUN, Creatinine and estimated glomerular filtration rate (GFR <15 mL/min/1.73 m2) Currently participating in any investigational studies not related to this study's preoperative or postoperative care, Patient has a mental illness or belongs to a vulnerable population (e.g., is a prisoner or a severe drug abuser, or is developmentally disabled) such that his or her ability to provide informed consent or comply with follow-up requirements is compromised, Patient is pregnant or interested in becoming pregnant in the next 2 years, (Due to the required x-rays for the study), Other severe acute or chronic medical condition that may interfere with the interpretation of the study results, in the judgment of the investigator, which would make the patient inappropriate for entry into this study.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Ceramic on metal prosthesis<br>Ceramic on metal prosthesis | Device: Ceramic on metal prosthesis<br>* Ceramic femoral head with a metal acetabular component<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint/Measures: Success at 24 Months | The patient success definition is measured at the 24 month interval by the following: Harris Hip Score (HHS) of > 80 • < 2mm radiolucency (width) in any Gruen (stem) or DeLee/Charnley (cup) zone and no more than mild pain. No revision or removal of any part of the device for aseptic reasons prior to or on day 730 following the index surgical procedure. A patient must meet all three criteria in the definition to be considered a success. A patient who does not meet all three criteria will be deemed a failure. The Harris hip score, is used to measure the outcome of total hip arthroplasty. Eight sections on the HIP are rated by the patient: pain, distance walked, activities, public transportation, support, limp, stairs and sitting. Total scores are out of 100 and grouped as follows: 90 - 100 Excellent,80 - 90 Good,70 - 79 Fair,60 - 69 Poor.< 60 Failed.Any score above 60 is acceptable, although the higher the score, the better the patient's overall adjustment after the surgery | 24 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Secondary Measures of the UCLA Functional Assessments | UCLA: University of California LosAngeles Activity Score UCLA score is a validated scoring system for hip replacement outcome, The single item UCLA scale asks patients to rate their activity level from 1 to 10, with 1 defined as no physical activity and 10 defined as regular participation in impact sports. The score is the higher the better. | 24 months | 
| WOMAC Raw Total Score | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations (range is 0-96). | 24 months | 
| Metal Ion Analysis (Unilateral Only):Serum Cobalt | Serum cobalt and chromium are recommended as the optimal tests for evaluation of joint implant wear, patients with CoM implants have elevated serum chromium and cobalt concentrations. Clinically important implant wear is indicated when serum chromium exceeds 15 ng/mL and cobalt exceeds 10 ng/mL; these symptomatic patients are likely to have significant implant deterioration. serum cobalt and chromium are highest in the first year after implant. In subsequent years, and after run-in wear (initial wear of a hip implant that produces the greatest amount of metal ion release), cobalt and chromium concentrations decline, then reach steady state around 3 years after implant. | 24 months | 
| Metal Ion Analysis; Unilateral Only; Serum Chromium | Serum cobalt and chromium are recommended as the optimal tests for evaluation of joint implant wear, patients with CoM implants have elevated serum chromium and cobalt concentrations. Clinically important implant wear is indicated when serum chromium exceeds 15 ng/mL and cobalt exceeds 10 ng/mL; these symptomatic patients are likely to have significant implant deterioration. serum cobalt and chromium are highest in the first year after implant. In subsequent years, and after run-in wear (initial wear of a hip implant that produces the greatest amount of metal ion release), cobalt and chromium concentrations decline, then reach steady state around 3 years after implant | 24 months |