Each year in the United States, more than 700,000 people undergo open-heart surgery via sternotomy. The sternotomy is the most commonly used incision in heart surgery and is often referred to as “cracking the chest.” This term refers to the breastbone (sternum) being cut down the middle to allow for access to the heart.Unlike nearly every other broken bone in the body, where metal plates and screws are used to increase stability and promote bone healing, wrapping surgical grade wire around the breastbone remains the primary technique for holding the bone pieces together.
In some instances, use of wires has resulted in significant movement of the breastbone,1, 2 and did not provide enough stability to support the bone.3
If this occurs, the bones may not heal back together and breastbone complications such as infection, pain, or delayed bone healing may occur.2, 3, 4, 5
Rigid fixation is the use of metal plates and screws to stabilize fractured (broken) bones. If a broken bone cannot easily be casted, such as the chest wall (also called the breastbone or sternum), rigid fixation can be used to stabilize the bone fragments.
Despite the adoption of rigid fixation techniques in nearly every other bone, wire closure remains the predominant method of sternal closure.6, 7, 8, 9
Traditional closure of the breastbone after open-heart surgery is done by wrapping surgical grade stainless steel wire around and through the bone halves and twisting them together to tighten; similar to using a twist tie.
Most surgeons who use wires will use multiple and place them along the length of the sternum, in-between the ribs.
SternaLock Blu is a rigid fixation system of metal plates and screws for use in sternal closure or sternal reconstruction procedures. These plates and screws are intended to remain as permanent fixtures that are not removed at a later time, unless removal is necessary to re-access the heart, or other complications, such as infection, arise.
The plates and screws provide added stability to the breastbone to help facilitate the breastbone healing process after the bone is cut open for heart surgery. If re-operation on your heart is necessary, the plates can be cut for re-accessing the heart.10
Rigid fixation is used to repair many bone fractures (bones broken by injury), except a sternotomy, which is the sawing of the breastbone in half to access the heart. As a leader in the musculoskeletal space, Zimmer Biomet recognized an opportunity to expand the benefits of rigid fixation to patients undergoing heart surgery.
The SternaLock Blu Study was designed by a team of heart surgeons and health economic researchers, and compared outcomes following sternal closure with SternaLock Blu or wire closure. A total of 236 patients (116 SternaLock Blu patients and 120 wire closure patients), undergoing elective heart surgery were enrolled at 12 hospitals in the United States. Patients were followed for six months to evaluate healing, clinical outcomes and costs.11, 12, 13
Patients treated with SternaLock Blu plates and screws had improved sternal healing, fewer breastbone complications and improved recovery as compared to patients treated with wire closure following open-heart surgery.11, 12, 13
Patient treated with SternaLock® Blu experienced improved and faster healing at three and six months.12
2.6x more patients healed at 3 months
Patient treated with SternaLock® Blu experienced fewer sternal complications.12
0% vs. 5% sternal complications rate
Patient treated with SternaLock® Blu spent fewer days in rehab hospitals or skilled nursing facilities.12, 13
237 total fewer days in rehab and recovery
Although SternaLock Blu patients in the SternaLock Blu Study had improved healing, zero breastbone complications, and spent fewer days in rehab facilities, each patient’s results will vary based on their risk factors.
These study results should not be construed as a substitute for reviewing all of the actual study information with your surgeon or physician. Only your surgeon can determine what closure method is appropriate for you. All results that reference the SternaLock Blu product are based on comparison to standard wire closure. 11, 12
To help minimize risk it is always important to follow your surgeon’s sternal precautions. Sternal Precautions are preventative guidelines provided by your surgeon to protect the breastbone and help reduce breastbone complications.
While uncommon, breastbone complications can occur during and after surgery. Breastbone complications include, but are not limited to:
Apart from the adverse effects there are always possible breastbone complications of any surgical procedure such as, but not limited to, infection, nerve or soft tissue (non-bone) damage, and pain which may or may not be related to the implant. Implanted metal plates and screws cannot replace normal healthy bone, and the device can break, bend or be damaged as a result of stress, activity, load bearing or inadequate bone healing. Continue with regular postoperative follow-up examination as long as the plates and screws remain implanted.
You are not a candidate for sternal plating if you have the following:
The information herein is of a general nature and does not represent or constitute medical advice or recommendations and is for general education purposes only. The information includes descriptions of a medical device that a thoracic (heart) surgeon may choose for patients undergoing open-heart surgery.
Zimmer Biomet manufactures medical devices, including metal plates and screws that may be used by your heart surgeon to hold together the sternum (breastbone) after heart surgery. We do not practice medicine; all questions regarding your medical condition must be directed to your doctor(s).
Results with breastbone (sternum) plates and screws (rigid fixation) will vary due to health, weight, activity and other variables. Not all patients are candidates for this product and/or procedure. Only a medical professional can determine the treatment appropriate for your specific condition.
Appropriate post-operative activities will differ from patient to patient. Talk to your surgeon about whether rigid fixation is right for you and the risks associated therewith, including but not limited to the risks of infection, implant wear, loosening, screw or plate breakage or incomplete bone healing.
For a complete list of risks associated with Zimmer Biomet’s rigid fixation system, see Patient Risk Information.
The SternaLock Blu study was funded by Zimmer Biomet.
All content herein is protected by copyright, trademarks and other intellectual property rights, as applicable, owned by or licensed to Zimmer Biomet or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Zimmer Biomet.