Faqs

The bones and bone marrow of the human body are made up of living cells that need a steady blood supply to stay healthy. If blood flow to these cells greatly decreases, the cells may die.

Avascular Necrosis (AVN) is a cellular death of bone component, which occurs when the blood supply to the bones is temporarily or permanently blocked. In the absence of blood, bone tissues die and bone collapses. If this condition isn’t treated, it leads to severe pain, resulting in Arthritis. Avascular Necrosisis also called Osteonecrosisor Aseptic Necrosis.

a). Many times, no trauma or disease is present. This is called "idiopathic osteonecrosis" -- meaning it occurs without any known  cause

b). Injury — Hip dislocations, hip fractures, and other injuries can damage the blood vessels and impair circulation to the femoral head

c). Alcoholism

d) . Corticosteroid medicines — Many diseases, such as asthma, rheumatoid arthritis, and systemic lupus erythematosus, are treated with steroid medications. Although it is not known exactly why these medications can lead to AVN, research shows that there is a connection between the disease and long-term steroid use.

e). Other medical conditions — AVN is associated with other diseases, including sickle cell disease, myeloproliferative disorders, Gaucher's   disease, systemic lupus erythematosus, Crohn's disease, arterial embolism, thombosis, and vasculitis

f). Decompression sickness from a lot of deep sea diving

AVN is most common in the hip and the shoulder, but can affect other large joints as well, such as knee, elbow, wrist and ankle. More than 20,000 people each year enter hospitals for treatment of Osteonecrosis of the hip. In many cases, both hips are affected by the disease.

Unfortunately many patients with AVN have had the disease for quite some time before symptoms are present. The initial symptoms are usually felt during activity and include pain or aching in the affected joint. Symptoms usually begin slowly and may initially be sporadic. Sometimes, the pain may begin quite suddenly. As the disease progresses, the pain increases and is associated with stiffness and loss of motion of the involved joint. Limping becomes common. The hip is the most common joint affected, and the pain is usually felt in the groin.

If a person is completely healthy, the risk of getting Osteonecrosis is quite less, probably less than one in 100,000 gets it. Another way to understand this is that most of the people who get AVN probably have an underlying health problem. Most patients are between 20 and 50 years old with an average age of 38. Patients over the age of 50 are likely to have developed AVN either by a fracture of the hip or more rarely in association with disease of the major blood vessels to the lower leg.Estimated 10,000-20,000 new patients are diagnosed each year, with the male: female ratio of 6:1.

a)      Core Decompression- This is a surgical procedure that involves taking a plug of bone out of the involved area. It is applicable for mild to moderate degree of involvement that has not yet progressed to collapse. Because this involves creating a hole in the bone, six weeks of protected weight bearing is necessary to avoid fracture through the hole. Pain relief from this procedure has been excellent, but it has not been as effective at delaying the progression of the disease in the long term. There is some controversy about this procedure with a few studies that have been reported showing generally poor results.

b)      Bone Grafting- When a section of the bone has died, as is the case in AVN, it does not spontaneously heal. One approach to this problem is to surgically remove the dead bone and fill the empty space with bone graft that is either taken from the patient (autograft) or from the bone bank (allograft). The success of this approach depends upon the quantity of bone that has died. Disadvantages of autograft include limited quantities of bone for harvest and donor-site morbidity. Disadvantages of allograft include delayed vascular penetration, slow bone formation, accelerated bone resorption, transmission of infection and lack of histocompatibility.

c)      Osteotomy- In osteotomy, the bone can be cut below the area of involvement and rotated or turned so that another portion of the bone that is not involved in the AVN can become the new weight-bearing area. These operations are not very common anymore, but may apply to special cases with smaller lesions.

d)      Autologous Bone Implantation (ABI- Ossron)-  Bone regeneration by autologous cell implantation is one of the most promising treatment concepts currently being developed.ABI is a patient specific, tailor made regenerative medical treatment and consists of ‘cutting-edge’ technology. If cultured autologous cells are successfully used for this treatment, some problems related to bone graft techniques might be overcome, such as donor site morbidity in autografts and immunological problems in allografts.As the amount of aspiration volume at one site is limited and the number of bone forming cells is small, it is assumed that the culturing of cells and their subsequent implantation is the most feasible method to overcome such a problem.

Autologous Bone Implantation (ABI) procedure involves 2 stages.

Stage 1: A biopsy is performed to collect the patient’s bone marrow which forms the source of osteoblasts that are to be cultured. It’s a minimally invasive procedure where needle is inserted in iliac crest/ hip bone and 3-5 ml marrow is aspirated. This procedure takes just 10 minutes.

Biopsy is then sent to laboratory where it is cultured and multiplied upto 50 million osteoblasts under highly stringent conditions for approximately 4 weeks. Once the cells reach desired number, date of implantation (stage 2) is decided.

Stage 2: Patient is admitted for second stage procedure. Cultured cells are mixed with a gel that acts as a scaffold, and this cell-gel mixture is implanted at defect site in a minimally invasive surgery. After surgery patient has to undergo proper rehabilitation therapy for regeneration of damaged bone.

Cultured Autologous Cell Technology has created a new dimension in tissue engineering and regenerative medicine. Few of the advantages are:

a)      Simple, fast, and minimally invasive surgical procedure

b)      Accelerated and effective bone formation

c)       Supports natural bone growth

d)      Shorter recovery and rehabilitation

e)      Poses virtually no risk of disease transmission to patient since it comes from patients own tissue i.e. autologous

f)       Provides optimal solutions against various problems raised by autografts or allografts

Processing of ABI-Ossron is done in state-of-the-art facility under highly controlled conditions. Laboratory facility is certified with:

a)      Good Manufacturing Practices (GMP)

b)      Good Laboratory Practices (GLP)

c)      Good Clinical Practices (GCP)

d)      Quality Management System (ISO 13485:2003)

In addition to these accreditations, certificate of analysis (COA) is provided by the laboratory to the patient for every Ossron product that passes all specifications given by regulatory norms.

Following the implantation, patients can immediately return to their daily routine and do not require hospitalization. Naturally, every case is different. In injury cases, the goal is to achieve full range of motion within 12 weeks. As a general guide, 4-5 months are required after the implantation for the osteoblasts to successfully attach and alleviate the symptoms. Most people can safely return to the physical activities they enjoyed before their injury, including all types of sports. However, for all patients, rehabilitation is vital to a successful outcome with Ossron

Approximate Cost Rs.3,00,000/- depending on the  hospital set-up where the procedure is done.