Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty

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.