Recent literature has shown clinical benefits of posteromedial translation using sublaminar bands, for treatment of AIS. Adolescent idiopathic scoliosis (AIS) is a tridimensional deformity that affects the trunk height changing both in coronal and sagittal profiles, with usually a loss of thoracic kyphosis and lumbar lordosis and a trend to cervical kyphosis.
The aim of surgical treatment is both to correct the deformity in the coronal plane and to restore a physiological sagittal alignment. Indeed, restoring physiological thoracic kyphosis should reduce the incidence of adjacent segment degeneration and progressive junctional malalignment.Various systems have been reported for correction of AIS, among which the all-screw construct is commonly considered the gold standard. However, this system has some limitations: a significant decrease in thoracic kyphosis, the difficulty of thoracic screw placement because of the smaller pedicle size and the wide variation in his morphological characteristics due to the vertebral dystrophy observed in the concavity of scoliosis , and the potential complications, such as neurologic lesions, vascular injuries, pleural tears and increased radiations exposure.
Spinal Fixation Band
It is a temporary orthopedic implant intended to provide stabilization during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
1.-Spinal trauma surgery, used in sublaminar or facet wiring techniques;
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
3. Spinal degenerative surgery, as an adjunct to spinal fusions.The device system is designed to be incorporated into constructs and used in conjunction with other medical device implants made of either stainless steel or titanium whenever “wiring’ may help secure the attachment of other implants.It stabilizes the spine as an adjunct to fusion in the correction of spinal deformities.
1.-NAJA® | Cousin
The NAJA™ System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
VIDEO Animation: NAJA
It consists of:
- A ligament allowing correction and stabilization of the levels, after tensioning
- A malleable metallic lead allowing guidance of the braid during surgery and attached to the ligament through a PET sheath. These parts are not intended for long term implantation
- A connector designed to be clipped on a rod holding the tension of the braid.
Each implant is provided with its own single-use tensioner enabling a precise and progressive correction along the spine. This powerful instrument provides the surgeon a tactile feedback of the tension applied.
The NAJA™ System may also be used in conjunction with other medical grade implants made of titanium or cobalt chrome alloy whenever “wiring” may help secure the attachment of the other implants.
Features and Benefits
- One single-use tensioner per implant: progressive and parallel correction along the instrumented levels; no instrument set management, no cleaning process.
- Optimized low profile position of the connector at the end of the procedure without tension modification
- Ligament with integrated lead to secure guidance through anatomical structures
- Two rod sizes available (5.5 and 6mm)
A stand-alone version of the system is also available: the ResCUBETM. It consists of the same ligament as the NAJATM and a cubic low-profile connector independent of any rod, designed to hold the tension applied on the ligament. One single use tensioner per implant is provided as well.
2.-JAZZ Posterior Fixation| Implanet
The JAZZ Posterior Fixation systems are temporary implants to be used in orthopedic surgery. The JAZZ systems are intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
VIDEO Animation: JAZZ Posterior
The JAZZ systems are designed primarily for a posterior fixation. The indications for use include the following applications:
- Traumatic spinal surgery, use in sub-laminar and interspinous cases and in facet connection techniques
- Surgery for spinal deformations such as scoliosis, kyphosis, lordosis, etc.
- Degenerative spinal surgery as a supplement to vertebral fusion, such as degenerative discopathy, stenosis, or spondylisthesis.
The JAZZ Systems may also be used in conjunction with other medical implants made of titanium alloy or Cobalt-chromium-molybdenum alloy whenever “wiring” may help secure the attachment of other implants.
The Jazz Claw System (hooks and rods) is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Jazz Claw System (hooks and rods) is intended for posterior fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis or revision of a failed fusion attempt.
The Jazz Claw System (hooks and rods) is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft.
Benefits:
- French design and manufacturing, in compliance with Directive 93/42/EC.
- Sterile implant.
- JAZZTM Band is designed for multiple union rod diameters: 3.5-4.5-4.75-5.5-6.0 mm.
- Unique implant : one size fits all levels.
- Primary stability on the rod : auto-stable / snap-on implant.
- Bone / implant interface : adapting and strapping the anatomical structures thanks to the braid.
- 2-in-1 rod and braid locking mechanism.
- Open flat polyester braid.
- Per-operative and post-operative intra-canalar follow-up : No metal part in the canal = no artifacts thanks to the braid.
- Single tensioning instrument for reduction and correction of the spine.
- 4-in-1 instrumentation for stabilization, snapping, unsnapping and counter-torquing/anti-rotation of the implant during final tightening.
- Optimized instrumentation only made of 6 types of instruments : reduces the number of surgical steps, simple, effective and easy to use.
- Reduced co-morbidity and bleeding compared to pedicle screws.
- Operative technique less risky than pedicle screw fixation
Product Brochure: Jazz Product and Surgical Technique Brochure
3.-SILC® | Globus Medical
SILC® is a low-profile fixation system that is easy to insert and provides the stability to perform standard reduction maneuvers without requiring pedicle purchase. This sublaminar polyethylene terephthalate (PET) band system adapts to complex anatomies of the most severe spinal deformities and utilizes the strength of laminar cortical bone, which may be necessary for compromised pedicle anatomy and/or poor bone quality. The top-loading clamp with medial/lateral set screw orientation allows implant insertion at any time during surgery.
Benefits:
- Intraoperative Versatility: Top-loading clamp in three sizes accommodates multiple patient types, correction techniques and rod diameters.
- Smooth Assembly: Streamlined Tensioner with simple steps for clamp insertion through final tightening.
- Strong Connection: The rigid clamp and SILC® band construct allows for powerful correction.
4.- Universal Clamp|Zimmer Biomet
The Universal Clamp spinal fusion device provides a stable interface between spinal anatomy and the rod through a pedicle-sparing band passage technique. The result is a spinal implant system that provides segmental stability, allows compression, distraction, derotation and translation while sparing the pedicles and reducing implant/bone contact stress. It can work alone or alongside hooks, screws and wires, enabling surgeons to perform translation, reduction, distraction and compression in situ. And it’s backed by the training service and expertise you’ve come to expect from Zimmer.
VIDEO Animation: Universal Clamp
Features:
The Universal Clamp spinal implant system consists of three sterile parts furnished together:
- One clamp
- One woven polyester band
- One locking screw
A great benefit of the system is its simplicity. It provides a straightforward process for progressive posteromedial translation of the spine. It offers the user the adaptability of hooks and the simplicity of sublaminar instrumentation. Elegantly simple, Universal Clamp instrumentation allows surgeons to leverage off the strengths of this versatile spinal implant to correct a variety of spinal pathologies. The innovation of the design provides 10 times less contact stress than with a hook and 17 times less than with a wire.
Product Brochure: Surgical Technique Universal Clamp.pdf
5.- NILE| Stryker (K2M)
NILE®Alternative Fixation Spinal System is a non-pedicle based fixation technology featuring low-profile, robust implants coupled with intuitive and light ergonomic instruments, providing a solution for the most complex deformity cases.
VIDEO Animation: NILE Alternative Fixation Spinal System
Features:
- Compatible with MESA Rail™ & Various Rod Sizes
- Independent Locking Mechanism to the Rod & Band
- No Threading or Assembly Required
- Streamlined Single Tray Set Configuration
6.- LigaPASS 2.0 | Medicrea
LigaPASS 2.0 provides a range of band connectors for posterior thoracolumbar fixation specifically adapted to meet unique clinical demands.
Benefits:
The growing LigaPASS® 2.0 Family of band connectors offers secure sublaminar and transverse process fixation in the thoracic and/or lumbar spine.With LigaPASS®, there is no compromise of fixation in demanding clinical scenarios, providing:
- The initial stability of a pedicle screw
- The ability to translate and derotate following the PASS LP® ST2R technique
- An optimal bone/implant interface
- A safe technique with single and dual band options
- An alternative point of fixation on existing constructs.
- The ideal accessory in deformity and revision cases
Product Brochure: LigaPASS Brochure.pdf
Features:
Continuity with PASS LP®
The LigaPASS® 2.0 band connector fits perfectly with the PASS LP® load-sharing reduction technique, ST2R (Simultaneous Translation on 2 Rods), and unique axial derotation technique using specialized connectors.
Safe Alternative
The LigaPASS® 2.0 Dual Band provides a safer and more efficient technique when applying multiple LigaPASS® connectors, requiring only 1 sublaminar pass finishing in 2 bands.
Ease of Use
The LigaPASS® 2.0 Family utilizes only a small tray of ergonomic instrumentation including self-stable tensioners and is compatible with Ti or CoCr rods between 5.5 and 6.0mm in diameter.
7.-BandLoc | Orthopediatrics
BandLoc 5.5/6.0mm System is a pedicle-sparing, sub-laminar polyester band technique for treating a wide variety of complex spinal pathologies – such as Scoliosis.
VIDEO Animation: BandLoc
The system features a unique pre-assembled implant design, which incorporates RESPONSE 5.5/6.0 set screw technology. The BandLoc system accepts both a 5.5 and 6.0mm rod diameter in CoCr and Titanium and features innovation, and simple tensioning instrumentation.