Inclusion Criteria
Patient 21 to 70 years of age
Cervical disc disease in 1 or 2 adjacent vertebral levels between C3-C7 defined as:
upper extremity radicular pain
subjects with myelo-radiculopathy
Failed non-surgical treatment of at least 6 weeks, or subject has progressive symptoms of nerve root or spinal cord compression
Minimum neck disability index score of ≥30% (15/50)
Must understand and sign ethics committee / institutional review board approved informed consent form
Able to meet follow-up schedule requirements and post-operative management program
If required, bone mineral density T-score of ≥ –1.5 SD as confirmed by DEXA
Exclusion Criteria
Degeneration at more than two cervical levels
Prior surgery at target levels (prior fusions C1-T1)
Cervical instability
Requires medications that interfere with bone /soft tissue healing
Metabolic bone disease or endocrine disorder affecting osteogenesis
Pregnant or wishing to become pregnant within 5 years
Alcohol or drug abuse
Pre-existing neurological abnormalities other then deficits produced from the spinal lesion
Involved in litigations or seeking permanent disability status
Inmate, HIV, metastatic cancer, presence of infection, morbid obesity, significant psychological disease, or allergy to a metal alloy or polyethylene
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( 3 / 131 )The Interventional Spine™ PERPOS™ System is a complete set of instruments engineered for percutaneous implantation of the BONE-LOK® Implant(s). The unique one-size fits all BONE-LOK Implant, with CLASP® technology, enables single or multi-level, bi-lateral fixation, without rods and screws, leaving less hardware in the patient while preserving the adjacent facet joint(s). Utilizing the Teleport® Tissue Retractor the surgeon can access the spine using only a single 15mm percutaneous entry site. This pathway allows the surgeon to dilate down to the vertebral level, with minimal disruption to the soft tissue, creating an 11mm working channel that accommodates the system’s components.
http://www.i-spineinc.com/
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Features
ODL (Open Door Laminoplasty) Spacers
The ARCH ODL allograft spacers, designed by and available
through Synthes Spine, are processed by the Musculoskeletal
Transplant Foundation (MTF). The allograft spacers
are designed to:
• Ease the surgical technique by eliminating the need
to shape the resected spinous process
• Securely fit the open door where the laminotomy has
been performed. Holes in the anterior and posterior sides
help to secure the allograft while the preshaped cortical
allograft fits the anatomy of the patient.
• Accommodate bone void fillers in the center of the allograft
Miniplates
The ARCH Fixation System miniplates are:
• Pre-bent (single bend and double bend) to fit
the anatomy of the dorsally elevated lamina
• Low profile to prevent tissue irritation
• Available in 5 sizes corresponding to the ARCH
ODL allograft spacers
• Made from commercially pure titanium
71/2°
Single bend
Available in 2 shapes (parallel and
angled) and 5 sizes (ranging from
4 mm to 12 mm, in increments
of 2 mm)
Notched ends
prevent the allograft’s
migration
Double bend
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( 3 / 141 )Ostim® is a ready-to-use, injectable bone matrix in paste form. It consists of 100% synthetic, nanoparticular, phase free hydroxylapatite.
Ostim® is used for filling in or reconstructing bone defects.
The Ostim® syringe in the double sterile pack can be used to apply paste to the bone defect directly or by means of applicators.
Ostim® does not harden off when mixed with blood or spongiosa, so it is highly suitable for increasing the volume of autologous or homologous material. The volume stability of Ostim® 35 enables it to resist bleeding pressure. Simultaneously, its viscosity enables it to be applied to form-fit in close contact with the bone.
Ostim® is suitable for making good defects in fractures in the spongy area. After repositioning the joint surfaces and mechanical stabilization, the defect is filled in with Ostim®.
Thanks to its paste-type properties, Ostim® is quickly converted into bone. New bone formation is visible after only three months.
Product Properties
Absorption
Ostim® has a nanocrystalline structure that makes it degradable in the organism.
Viscosity
Ostim® does not harden off and is therefore quickly absorbed by macrophages and osteoclasts. The defect is set in the customary way using the usual osteosynthesis measures.
Vascularization
Because of early vascularization, which is detectable after 7 to 10 days, cells can migrate into the Ostim® matrix, absorb it and form new bone in parallel with this.
Bone formation
Ostim® accelerates the rate at which bone-forming cells proliferate and stimulates bone healing. Bone builds up very rapidly. Ostim® is fully absorbed after just a few months and the defect has been completely and stably filled in by bone.
Building of load-bearing capacity
Depending on the osteosynthesis measures used, consistent mechanical stability is achieved and is no different from usual.
Indications:
Metaphyseal fractures and cysts
Acetabulum reconstruction and periprosthetic fractures during hip prosthesis exchange operations
Osteotomies
Filling cages in spinal column surgery
Combination with autogenous and allogenous spongiosa
Filling in defects in children
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( 2.9 / 150 )The various sterile components/items are assembled in sets or packed individually in a sterile barrier system. The sterile barrier system prevents ingress of micro-organisms and allows aseptic presentation of the product at the point of use.
The packaging materials used in the sterile barrier system are adapted to the sterilisation method required by the product materials.
Mölnlycke Health Care recommends that BARRIER products are stored under normal storage conditions. All layers of packaging should be kept intact until access to the underlying layers is needed.
Storage facilities for products only protected by the sterility barrier should be kept under conditions where low level of particulate air contamination prevail, so that´it would not constitute a risk to the patient when the package is opened and the product is used.
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