What is the BIRMINGHAM HIP (BH) Modular Hip System Compassionate Use?
This is a compassionate use clinical study. The study was designed to evaluate the performance of the BIRMINGHAM HIP (BH) Modular Hip System in patients requiring revision of their BHR femoral component. The compassionate use study is to provide a surgery option to patients who require a revision of their BHR femoral component but where the acetabular cup will be left in place due to minimal amount of damage. If a patient requires removal of the femoral resurfacing head, the only current option is the removal of all of the BHR components, including the acetabular cup that is not defective. There is currently no FDA cleared or approved device that can be used with the acetabular cup so that less invasive surgery (non-removal of the functioning acetabular cup) can be performed.Who is eligible for this study?
Center for Orthopaedics is seeking patients that had the BIRMINGHAM HIP Resurfacing femoral component that failed after surgery and an acetabular cup that will not be revised due to minimal amount or lack of cup damage, surface scratching, subsidence, radiolucency, or osteolysis. The patient will have to obtain an independent assessment by an uninvolved physician.Are there additional costs?
All costs associated with the joint replacement procedure will be billed to the patient or patient's insurance provider. In cases where this study requires procedures or examinations that differ from those normally required of patients receiving a total hip replacement, all additional costs of the study will be paid by the study Sponsor, Smith & Nephew. There will also be small payments (in the form of a gift check) available to study participants each time they return for a research visit or respond to study post-cards. Your surgeon will have the specific amounts available.Where is the surgery performed?
The surgery will be performed at CHRISTUS St. Patrick Hospital located at 524 Dr. Michael DeBakey Drive, Lake Charles, Louisiana 70601.What is involved and how long will the study last?
Informed Consent Form. If a patient meets all inclusion and exclusion criteria and voluntarily agrees to participate in the study, the patient will be asked to sign the consent form presented. Pre-Operative Assessments. Collect medical history, demographic information, and perform metal ion testing (blood collection). Operative and Discharge Data will be collected. Patients will be seen at 3 months, 6 months, 1 year, and 2 years post-surgery. Clinical information will be collected at each visit. Metal ion testing (blood collection) and x-rays will be performed at Discharge, 1 year and 2 year intervals. Patients will be seen biennially thereafter until the study is closed or no longer required by the Food and Drug Administration (FDA).Are there additional risks or benefits?
There are risks associated with a total hip arthroplasty that may result from the surgery itself, the device implanted, or the instrumentation used to implant the device. The risk of this surgery will be explained to each patient in detail as part of the consent for surgery. The potential benefits of the BIRMINGHAM HIP Modular Hip System will provide the surgeon and patient with an alternative treatment. A benefit of this surgery is that the surgeon and patient will have a less-invasive revision option. The BHR acetabular cup that is not defective is compatible with the BIRMINGHAM HIP Modular Hip System. Patients have the option of not having any surgery or having surgery that involves the removal of all hip resurfacing components including the functioning acetabular cup and obtaining another total hip system.Why should I participate?
A maximum of 8 clinical sites in the USA will participate in this study. A 2 year study endpoint has been proposed to provide sufficient time to evaluate safety and effectiveness of the modular head and sleeve with the previously implanted acetabular cup. If eligible and you choose to be a study participant, you will be one of a limited number of patients at this clinical site chosen to take part in this important clinical study.What if I decide not to participate?
Your participation in this study is entirely voluntary. Patients may decide to withdraw from the study at any time. Regardless of your choice, the quality of care provided by your surgeon will remain the same.Who is Smith & Nephew?
Smith & Nephew is a leading orthopedic company that manufactures artificial joints, trauma products, and other devices used in the practice of orthopaedic surgery. Smith & Nephew is the sponsor of this clinical investigation.Smith & Nephew, Inc.
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Memphis, TN 38116 USA
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For additional information on this study, please call 337-312-8405 or 312-8404.