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BIRMINGHAM HIP Resurfacing System (BHR)

BIRMINGHAM HIP Resurfacing System (BHR) - Hip Implant Device

ENROLLMENT OPEN

The purpose of the BIRMINGHAM HIP RESURFACING (BHR) Clinical Study is to collect additional information on the performance of this particular type of hip implant device.

What is a BHR device?

Your hip is a socket and ball joint where the thighbone and pelvis come together. As your leg moves, the ball of your thighbone (called the femoral head) moves and rotates against the socket portion of your pelvic bone (called the acetabulum). If your hip joint is diseased due to certain kinds of arthritis, or previous damage, it will likely become less functional and more painful over time. When your hip pain increases to the point that it can not be helped by usual measures such as pain medicine and exercises (physical therapy) and your ability to move your hip decreases, affecting your ability to do your daily activities, it may become necessary to surgically replace the hip joint.

Hip joint replacement relieves hip pain and improves hip function by replacing the parts of your hip that have been severely damaged by degenerative joint diseases. The names of such diseases include osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis.

The most common procedure to surgically replace the hip joint is to undergo a total hip replacement. The ball joint is completely removed and replaced with a metal ball and stem. A shallow cup is placed in the socket. In contrast, in surgery using the BHR◊ device, the ball joint is not completely removed, but a cap is placed over the ball joint. A shallow cup is placed in the socket just like the total hip joint procedure. The BHR system spares more of the hip joint bone compared with the total hip replacement devices. In the BHR, the surfaces that rub against each other are made from highly polished metal. This type of device is called a metal-on-metal.

The BHR◊ device is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint replacement.

What clinical information is already available for the BHR device?

The BHR device has been put in over 30,000 patients in the United Kingdom (UK), Europe and Australia. In a study of over 2,000 patients in the UK, the rate and types of problems seen with the BHR device were similar, but not identical to the problems reported for other hip replacement devices.

The BHR device has recently been approved by the Food and Drug Administration (FDA) for use in the United States. This clinical study will collect information similar to what was collected in the UK study.

Who is eligible for this study?

Generally, males and females 21 years of age or older who are diagnosed with an arthritic condition requiring total hip replacement may be considered. Other considerations, such as medical history, must be evaluated by your surgeon before offering you the choice to participate in the study.

Are there additional costs?

All costs associated with the joint replacement procedure will be billed to the patient or patientís 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. As a result, no additional costs to you are anticipated. 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 West Calcasieu Cameron Hospital located at 701 Cypress Street, Lake Charles, Louisiana 70663.

What is involved and how long will the study lasts?

The study is expected to last 10 years or more. The follow-up visits required by your surgeon may be the same as if you were not participating in the study. This study requires office visits with your surgeon at the following intervals:

3 months

  • 1 year
  • 2 years
  • 3 years
  • 4 years
  • 5 years
  • 10 years

At each office visit, blood work and x-rays of your hip are required and you will be asked to complete a short questionnaire about your overall health. A post-card asking simple questions about the status of your hip will be sent to you in post-operative years 6, 7, 8, and 9.

Are there additional risks or benefits?

Yes, there are additional risks and benefits compared with a total hip joint replacement. Potential benefits include a lower incidence of dislocation, and less removal of bone, possibly making future revision surgery easier in some cases. The BHR does not cause thighbone fractures like the risk associated with total hip replacements. Potential risks include femoral neck scratching, femoral head collapse and blood circulation problems (avascular necrosis). This study will require small blood samples from each study participant at 8 different intervals. Please ask your surgeon to explain all of the risks and potential benefits to you in detail. The Informed Consent form for this study has much more detailed information about risks, benefits, and study requirements.

Why should I participate?

Your surgeon is one of a select group of United States physicians participating as an investigator in this study of the BHR device. Smith & Nephew is collecting this data in order to analyze additional information on this FDA approved device. If eligible and you choose to be a study participant, you will be one of approximately 400 patients across the country that will be selected by their surgeon to participate in this important clinical investigation.

What if I decide not to participate?

Your participation in this study is entirely voluntary. Furthermore, you 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.

7135 Goodlett Farms Parkway

Cordova, TN 38016 USA

Toll Free: 800-821-5700

For additional information on this study, please call 337-312-8405 or 312-8404.

http://www.birminghamhipresurfacing.com

http://clinicaltrials.gov/ct2/show/NCT00611585


 

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