← Back to all trials
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.
Source: ClinicalTrials.gov (NCT01307384). StuddyBuddy aggregates publicly available trial information.