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Completed NCT01307384

Zimmer Continuum Metal on Polyethylene (MoP) PostMarket Clinical Followup (PMCF) Study

Conditions: Avascular Necrosis, Osteoarthritis, Inflammatory Arthritis, Post-traumatic Arthritis, Rheumatoid Arthritis

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Enrollment: 195
Sponsor: Zimmer Biomet

Location: Sah Orthopaedic Associates Fremont California

Summary

This is a prospective, multi-center, non-randomized, non-controlled study designed to obtain survival and outcome data on the Continuum Metal on Polyethylene Acetabular System when used in primary total hip arthroplasty.

Eligibility Criteria

Inclusion Criteria * Patient is 18 to 75 years of age, inclusive. * Patient is skeletally mature. * Patient qualifies for primary unilateral or bilateral (simultaneous or staged) total hip arthroplasty (THA) based on physical exam and medical history including the following: * Avascular necrosis (AVN) * Osteoarthritis * Inflammatory arthritis (i.e., Rheumatoid arthritis) * Post-traumatic arthritis * Patient has no history of previous prosthetic replacement device of any type, including surface replacement arthroplasty, endoprosthesis, etc. of the affected hip joint(s). * Patient has moderate, marked or disabling pain. * 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 IRB 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 neurologic condition in the ipsilateral 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 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 affected 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 and/or cysts in the operative hip. * The patient has a Body Mass Index (BMI) \> 40.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT01307384). StuddyBuddy aggregates publicly available trial information.