Frequently asked questions

Included below are some frequently asked questions about bone cysts, tumors and Pro-Dense Injectable Regenerative Graft. However, these are not all-inclusive. Consulting a physician to learn more about treatment options and to answer any questions you may have is important. Only a physician can tell you if Pro-Dense Graft and the associated procedures discussed on this website are right for you or your child and any unique circumstances. Not everyone is a good candidate for Pro-Dense Graft. Evaluating whether it’s appropriate involves substantial discussion with a physician to adequately evaluate risks and benefit information including general risks and unique patient circumstances.

What is a benign bone cyst or tumor?

This is a condition in which bone is replaced with fluid or abnormal tissue resulting in a bone void. There are many different types of cysts or tumors that present in different places in the skeleton and are common to different age groups including children and adolescents. These voids can lead to weakened bone and result in pain and/or fracture. It is important to understand that most of these tumors are actually benign (i.e., not cancerous) and do not spread to other parts of the body. They can often be treated non-surgically, and surgical treatment can be minimally invasive depending on the type of cyst involved.

How do bone cysts and tumors form?

Unfortunately, this is not entirely well understood for some cysts and tumors. There are different causes for the different lesions, which can make it difficult to determine how and where they come from. A surgeon will discuss your or your child’s condition with you for better understanding.

Is the cyst/tumor cancer?

Benign bone tumors/cysts are not cancers and never metastasize or spread to other parts of the body. These tumors are typically localized and can be healed with the right treatment, although some can be persistent or recur.

Which cysts/tumors are treated conservatively and which are treated with surgery?

The answer to this question is likely dependent on several factors, such as the type of cyst/tumor, the size and location, and aggressive nature among others. However, in general, if the lesion is relatively small and not in danger of fracture, and appears to have a more latent appearance (i.e., isn’t growing fast), a conservative treatment option may be available. Please consult your physician.

How is a cyst/tumor treated surgically?

Again, depending on several factors, the cyst/tumor may be accessed with a small incision and injected, or may require more exposure of the bone with removal and bone grafting. A surgeon will assess these various factors and will choose the best approach based on his or her experience.

What is Pro-Dense Injectable Regenerative Graft and how does it work?

Pro-Dense Graft is a synthetic composite of calcium sulfate and calcium phosphate, two biocompatible materials that have been used in bone grafting for over 100 years.1 The composite is unique in how it resorbs in the body, and how the body responds by laying down dense new bone. Pre-clinical work and clinical experience demonstrate that the rate at which the body resorbs the Pro-Dense Graft and replaces it with newly regenerated bone seems to be timed just right.

What are the risks of Pro-Dense Injectable Regenerative Graft?

There are always risks inherit in any surgical procedure. A surgeon must evaluate the appropriateness of the procedure based on personal medical training and experience. Certain individuals should not undergo surgery. And, for certain individuals, this product may not be the best treatment option. For example, patients with pre-existing conditions, severe vascular or neurological disease, or patients who are pregnant may not be the best candidate for Pro-Dense Graft.

Possible adverse effects include but are not limited to:

  • Wound complications including hematoma, site drainage, bone fracture, infection, and other complications that are possible with any surgery
  • Fracture or extrusion of the bone void filler, with or without particulate debris generation
  • Deformity of the bone at the site
  • Incomplete, or lack of, osseous ingrowth into bone void, as is possible with any bone void filler
  • Transient hypercalcemia
  • Potential to pressurize material in a closed void, which could result in fat embolization and/or embolization of the device material into the blood stream

For more information on risks, specific to this product, please consult the Indications & Contraindications page of this website.

References:
  1. Dreesmann H: Knochenplombierung bei Hohlenforigen Defekten des Knochens. Beitr Klin Chir 9:804-810, 1892
Important information

Individual results and activity levels after surgery vary and depend on many factors including age, weight and prior activity level. There are risks and recovery times associated with surgery and there are certain individuals who should not undergo surgery. Only a physician can tell you if this product and associated procedure are right for you and your unique circumstances. Please consult with a physician for complete information regarding benefits, risks, anticipated implant duration and possible outcomes.

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the breadth of Stryker’s product offering. A surgeon must always refer to the package insert, product label and/or instructions for use, including the instructions for cleaning and sterilization (if applicable), before using any of Stryker’s products. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your representative if you have questions about the availability of Stryker’s products in your area.

Stryker or its affiliated entities own, use, or have applied for the following trademarks or service marks: Stryker. All other trademarks are trademarks of their respective owners or holders.

The absence of a product, feature, or service name, or logo from this list does not constitute a waiver of Stryker’s trademark or other intellectual property rights concerning that name or logo.


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