Ceramic on Metal Total Hip Replacement System Multi-Center,Investigational Device Exemption Clinical Trial
Condition: Total Hip Replacement System
Intervention: Ceramic on metal prosthesis
Intervention description: Ceramic femoral head with a metal acetabular component
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 253.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must be 18 years of age or older at the time of enrollment,

          2. Patient is skeletally mature,

          3. Evidence of a signed and dated informed consent document indicating that the patient
             has been informed of all pertinent aspects of the study,

          4. 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)

          5. Investigator determines patient is a suitable candidate for primary total hip
             replacement,

          6. Body Mass Index (BMI) of <40,

          7. Preoperative Harris Hip Score (HHS) < 70 points as calculated on the Pre-screening
             Qualification Form and verified by the Sponsor,

          8. Have a diagnosis of degenerative joint disease of the hip.

        Exclusion Criteria:

          1. Previous total hip replacement, hemi-arthroplasty, or fusion on the ipsilateral side,

          2. Patients with a previous Girdlestone procedure,

          3. Patient has a known metal allergy to any component of the investigational device
             (e.g.cobalt, chromium, titanium or ceramics),

          4. Patient has had a total knee arthroplasty of either leg,

          5. Patient has vascular insufficiency, muscular atrophy, or neuromuscular disease in the
             affected limb (based on the Investigator's discretion),

          6. 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),

          7. 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),

          8. 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),

          9. 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,

         10. Active malignancy,

         11. Patient has an active infection (e.g. hepatitis, AIDS, ARC or is HIV positive)-
             systemic or at the site of intended surgery,

         12. 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)

         13. Currently participating in any investigational studies not related to this study's
             preoperative or postoperative care,

         14. 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,

         15. Patient is pregnant or interested in becoming pregnant in the next 2 years, (Due to
             the required x-rays for the study),

         16. 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.