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Fraclink

Fraclink
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Fraclink

Large bone defects are serious complications that are most commonly caused by extensive trauma, tumors, infection, or congenital musculoskeletal disorders. Bone defect healing is a process of reconstruction of the bone tissue, which undergoes a multidimensional procedure with an overlapping timeline. However, the healing process of bone defect is time consuming, and new bone generation takes place slowly because of decreased blood supply to the fracture site and insufficiency of calcium and phosphorous to strengthen and harden new bone. In addition, critical bone defects may not heal spontaneously and lead to non-union prognosis due to size of defects or unstable biochemical properties, unfavorable wound environment, suboptimal surgical technique, metabolic factors, hormones, nutrition, and applied stress.

 

Traditionally, the use of autologous grafts has been considered ideal; it still has disadvantages such as limitation in donor supply, donor site pain, or hemorrhage. Disadvantages of allograft are the risk of immune-mediated rejection, the transmission of infectious diseases and negative effect on the mechanical and biological properties of graft.

In order to overcome the limitations associated with the current standard treatment of bone grafts, there has been increased interest in using substitute biomaterials, which are synthetically derived. The ideal bone graft substitute should be biocompatible, bio-resorbable, osteo-conductive, osteoinductive, structurally similar to natural bone, and easy or ready to use.

Method of Application

FRACLINK™ Granules or Blocks are generally wetted with patients blood or saline solution and are placed directly on the application area followed by sutures. Porous structure promotes colonization of Osteogenic cells from the patients blood. For large cavities, bigger sizes Granules / Pre-forms may be used together with patient's own bone.

 

FRACLINK™ Materials

FRACLINK™ Materials are, chemically derived and synthesised at high temperatures as per know-how developed by SCTIMST, Thiruvananthapuram.

  • This product contains hydroxyapatite, the bone mineral, synthetically prepared through a patented process and made into porous granule form. It is specially designed for the use as a bone defect filler. The surfaces are osteoconductive and the porosity allows the in-growth of the new bone, thereby providing excellent osteointe-gration.
  • Characterized for purity, chemical composition, particle size distribution bio-compatibility.
  • As per clinical, radiological and histo-morphological studies, suitable for filling traumatic and or pathological bone defects.

 

Properties

Bio Compatible : Excellent bio compatibility and binds directly to bone.

Non Immunogenic : Surrounded by Cellular infiltrate which is predominantly fibroblastic.

  • No Lysis of RBC
  • No Cytotoxic effect on surrounding cells
  • No tissue necrosis

Osteo Conductive : Bonding with Bone commences within three months, fastest of all Ceramic constituents.

  • Ca/P ratio is similar to that of human bone.
  • Crystalline structure and morphology similar to natural bone.

 

Contra-Indications

  • Infections, Sepsis
  • Load bearing Bone defects with no external and/or internal support.
  • Abnormal metabolism of bone elements such as Ca/P
  • Metabolic disorders which may impair bone formation.

 

Precautions

  • For single use only. Do not reuse or resterilize.
  • Not intended for immediate load bearing application.
  • Do not over fill defects.
  • Do not leave defect open.
  • Do not compromise blood supply to the defect area.
  • Please apply immediately to application area on opening the sterilized pack.
  • Surgical procedure should be carefully planned by surgeon to avoid infection and should not be used in infected area or secondary wounds.
  • Do not use if package is open or damaged or if expiry date is exceeded.

 

DISCLAIMER :

Onyx Medicals Pvt. Ltd. (OMPL) has exercised maximum possible care in the production and packaging of this product. OMPL excludes all warranties, whether expressed or implied by operation of law or otherwise, including but not limited to any implied warranties of merchantability or fitness for a particular purpose. OMPL shall not be liable for any incidental or consequential loss, damage or expense, directly or indirectly arising from use of this product. OMPL neither assumes nor authorize any other person to assume for it, any other or additional liability or responsibility in connection with this product.