Patient Information - Bone Grafting Choices

Bone Grafting Choices:

Many surgical procedures of the spine, pelvis and extremities require that a "bone graft" be added to the surgical site. Bone grafting procedures are used to regenerate bone that has been removed or damaged due to disease and trauma.

Historically, surgeons have chosen to surgically remove healthy bone from the iliac crest (autograft), and place it into the desired location, a procedure known as iliac crest bone grafting (ICBG). While effective and considered to be the "gold standard," this procedure requires additional surgical time and can sometimes produce post-operative pain.

Another option for patients is bone from human donors, called allograft bone. This bone is harvested from a cadaver, then processed and prepared for implantation. Although cadaver bone allograft products have been used for many years, the risk of disease transmission can never be completely eliminated. The most common allograft bone products in use today are processed bone chips, demineralized bone matrix (DBM) products and structural bone implants.

Advancements In Bone Grafting:

As new biosurgical technologies are developed, surgeons have more advanced options from which to choose. Your surgeon may decide to use a synthetic alternative to human and cadaver bone, like Vitoss (vee-toss). Vitoss may be used for surgical procedures of the spine, pelvis and extremities that require a "bone graft". Patients may appreciate the benefits of receiving Vitoss for the following reasons:

Vitoss is an FDA cleared, completely synthetic biomaterial made from calcium and phosphate, engineered to resemble the structure and chemistry of human cancellous bone, just like autograft. By using Vitoss, the surgeon can eliminate the additional surgical time and post-operative pain sometimes associated with iliac crest bone grafting (ICBG).

In addition, when receiving Vitoss, patients can avoid the possibility of receiving cadaver bone allograft chips and DBM products, along with the risk of disease transmission which can never be completely eliminated when cadaver bone products are used.

The Biology Of Bone Remodeling

The "Gold Standard" Iliac Crest Bone Graft (ICBG)

Major Advance in the Science of Bone Regeneration

Vitoss "The Synthetic Gold Standard"

In order for new bone to form, three critical elements are required: an osteoconductive Scaffold, osteogenic Cells, and osteoinductive Signals. The ideal scaffold acts as a porous matrix or framework for new bone, which resorbs completely, leaving new healthy bone in its place. Cells are the "factories" that produce bone tissue. Biologic signals during this process tell the cells how and when to execute the bone regeneration process.

Vitoss provides the Scaffold. Its unique, patented structure permits cells to infiltrate the matrix, and then allows for critical biologic signals and nutrients to pass through in order to support the cellular activities. To obtain the cells and signals, your surgeon will either incorporate local autograft from the surgical site, place Vitoss into a bone marrow rich skeletal location, or obtain bone marrow aspirate (BMA) and combine Vitoss with BMA.

There are differences between the various bone grafting materials and options used in medical practice today, and many different options are available to surgeons. It is important to utilize a bone graft material where the efficacy of the graft has been proven in human clinical trials.

Frequently Asked Questions

How does a bone graft work?

By using a Scaffold (like Vitoss) in combination with Cells and Signals, it is possible to regenerate healthy new bone for a wide range of surgical procedures.

What are the various options available for bone grafting?

Autograft - the patients' own bone, often harvested from the hip or local surgical site.
Allograft/DBM - donated cadaver bone tissue processed for human implantation.
BMPs - proteins that induce the formation of cartilage and bone
Synthetics - synthetic materials manufactured with chemistry similar to bone (CaP)

Why would my surgeon seek an alternative to autograft or allograft?

Although autograft is considered to be the "gold standard" of bone grafting, often times the volume needed for the grafting procedure cannot be obtained. Autograft harvest adds time to the surgery, and about 20-30% of patients undergoing autograft harvest from the hip experience post-operative pain for 6 months - 2 years following surgery.

Although allograft can be a replacement for autograft, the biological healing properties are not as good as autograft. Additionally, there can be variability between different lots of allograft. There is also a potential risk of infection or disease transmission from allograft tissue that can never be completely eliminated.

What is Vitoss?

Vitoss is a patented, synthetic Calcium Phosphate scaffold with a unique structure, chemistry, and porosity engineered to resemble human cancellous bone.

What is BMA?

Bone marrow aspirate (BMA) is harvested from the iliac crest, or the surgical site, during surgery using a special needle. Bone marrow is one of the most active organs in your body and produces stem cells that regenerate bone and other tissue. It has been shown that the addition of BMA to bone graft materials like Vitoss, is an effective bone graft substitute similar to ICBG

What are the advantages of Vitoss?

Vitoss has been FDA cleared for use in the spine, extremities, and pelvis since 2001 and has been safely used in over 100,000 patients to date.

Vitoss has also been used in a number of prospective and retrospective human clinical studies which have demonstrated equivalence to iliac crest autograft, the gold standard