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SternaLock® Blu Study & Product

History of Breastbone Closure

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

Product Information 1

What is rigid fixation?

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

Product Information 2

What is wire closure?

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.

What is SternaLock Blu?

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

 

What is the SternaLock Blu Study?

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

Product Information 3

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

 

What are the risks associated with sternal closure? 10

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:

  • Poor bone conditions can cause the plates or screws to fracture
  • Incomplete bone healing or delayed healing
  • Allergic reaction to metal plates and screws
  • Decrease in bone density
  • Shifting, bending, breaking or loosening of plates and screws
  • Pain, discomfort, abnormal sensation, or palpability due to the presence of the plates and screws
  • Inflammation around the fracture site and/or the plates or screws
  • Poor healing of the bone
  • Decomposition of bone
  • Improper selection of screws that are too long for the thickness of the breastbone may protrude to the interior of the chest.

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:

  • Current, active infection
  • Specific metal allergy or sensitivities
  • Mental condition preventing compliance with postoperative care instructions
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References

  1. Losanoff J.E., Basson M.D., Gruber S.A., Huff H., and Hsieh F.H., Single wire versus double wire loops for median sternotomy closure: experimental biomechanical study using a human cadaveric model. Ann Thorac Surg, 2007. 84(4): p. 1288-93.
  2. Losanoff J.E., Collier A.D., Wagner-Mann C.C., Richman B.W., Huff H., Hsieh F., DiazArias A., and Jones J.W., Biomechanical comparison of median sternotomy closures. Ann Thorac Surg, 2004. 77(1): p. 203-9.
  3. Schimmer C., Reents W., Berneder S., Eigel P., Sezer O., Scheld H., Sahraoui K., Gansera B., Deppert O., Rubio A., Feyrer R., Sauer C., Elert O., and Leyh R., Prevention of sternal dehiscence and infection in high-risk patients: a prospective randomized multicenter trial. Ann Thorac Surg, 2008. 86(6): p. 1897-904.
  4. Pai S., Gunja N.J., Dupak E.L., McMahon N.L., Roth T.P., Lalikos J.F., Dunn R.M., Francalancia N., Pins G.D., and Billiar K.L., In vitro comparison of wire and plate fixation for midline sternotomies. Ann Thorac Surg, 2005. 80(3): p. 962-8.
  5. Claes L, Augat P, Suger G, Wilke HJ. Influence of size and stability of the osteotomy gap on the success of fracture healing. J Orthopaed Research 1997;15:577-84.
  6. Newman K. History of the AO: The first 50 years. https://www.aofoundation.org/Structure/the-ao-foundation/about/Pages/history.aspx
  7. http://en.wikipedia.org/wiki/Intramedullary_rod
  8. Smith SC, Pelofsky, S. Adaptation of rigid fixation to cranial flap replacement. Neurosurgery 1191; 29(3):417-418.
  9. http://www.burtonreport.com/infspine/surgstabilpedscrews.htm
  10. SternaLock Blu IFU 01-50-1215
  11. CR 0712S (Clinical Study Report) SternaLock Blu Study, 2014-15, an evaluation of rigid plate fixation in supporting bone healing: a prospective, multi-center trial of 236 total patients undergoing full midline sternotomy.
  12. CR 0712E (Economic l Study Report) SternaLock Blu Study, 2014-15, an evaluation of rigid plate fixation in supporting bone healing: a prospective, multi-center trial of 236 total patients undergoing full midline sternotomy.
  13. SternaLock Blu patients spent a total of 237 total fewer days in rehab hospitals or skilled nursing facilities over 6 months. 705 total days for wire cerclage patients (n=120) vs. 468 total days for SternaLock Blu patients (n=116).

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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.

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